Trial | Outcome |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit |
NCT00690378 (20) [back to overview] | Clinical Outcome in CE Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome in ME Patients at the End of IV Therapy Visit |
NCT00690378 (20) [back to overview] | Microbiological Outcome in ME Patients at the LFU Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response at the Late Follow-up Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response at the Test of Cure (TOC) Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response in CE Participants at the End of IV Therapy |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Microbiological Response at the End of IV Therapy |
NCT00752219 (10) [back to overview] | Number of Participants With Microbiological Response at the Test of Cure Visit |
NCT00752219 (10) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT00752219 (10) [back to overview] | Number of Participants With Microbiological Response at the Late Follow-up Visit |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at LFU (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) |
NCT01595438 (63) [back to overview] | Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) |
NCT01595438 (63) [back to overview] | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) |
NCT01595438 (63) [back to overview] | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) |
NCT01595438 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) |
NCT01599806 (63) [back to overview] | Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) |
NCT01599806 (63) [back to overview] | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) |
NCT01599806 (63) [back to overview] | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) |
NCT01599806 (63) [back to overview] | Per-patient Microbiological Response at LFU (mMITT Analysis Set) |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at FU2 in EME at FU2 Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at FU1 in EME at FU1 Analysis Set. |
NCT01644643 (38) [back to overview] | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. |
NCT01644643 (38) [back to overview] | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. |
NCT01644643 (38) [back to overview] | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set |
NCT01644643 (38) [back to overview] | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at TOC in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at FU2 in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at FU1 in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set |
NCT01644643 (38) [back to overview] | Per-patient Microbiological Response at EOT in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set |
NCT01644643 (38) [back to overview] | The 28 Days All Cause Mortality Rate in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set |
NCT01644643 (38) [back to overview] | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Response at TOC in EME at TOC Analysis Set. |
NCT01644643 (38) [back to overview] | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set |
NCT01644643 (38) [back to overview] | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set |
NCT01644643 (38) [back to overview] | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set |
NCT01689207 (7) [back to overview] | Safety Profile - Number of Subjects With at Least 1 AE |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NCT01689207 (7) [back to overview] | PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | Safety and Tolerability:ECG , QTcB and QTcF Intervals |
NCT01726023 (41) [back to overview] | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. |
NCT01726023 (41) [back to overview] | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. |
NCT01726023 (41) [back to overview] | Safety and Tolerability by Incidence: Extent of Exposure. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. |
NCT01726023 (41) [back to overview] | The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. |
NCT01726023 (41) [back to overview] | The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. |
NCT01726023 (41) [back to overview] | Plasma Concentrations for Ceftazidime and Avibactam |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. |
NCT01726023 (41) [back to overview] | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 |
NCT01808092 (49) [back to overview] | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit |
NCT01808092 (49) [back to overview] | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
NCT01808092 (49) [back to overview] | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) |
NCT02475733 (26) [back to overview] | Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) |
NCT02475733 (26) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 |
NCT02475733 (26) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit |
NCT02475733 (26) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit |
NCT02475733 (26) [back to overview] | Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms) |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population |
NCT02475733 (26) [back to overview] | Plasma Concentrations of Ceftazidime and Avibactam |
NCT02475733 (26) [back to overview] | Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters |
NCT02475733 (26) [back to overview] | Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population |
NCT02475733 (26) [back to overview] | Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population |
NCT02475733 (26) [back to overview] | Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit |
NCT02475733 (26) [back to overview] | Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit |
NCT02497781 (29) [back to overview] | Change From Baseline in Body Weight at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Change From Baseline in Body Temperature at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR) at TOC: Clinically Evaluable (CE) Analysis Set at TOC |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR) at End of Treatment (EOT) Visit: Clinically Evaluable (CE) Analysis Set at EOT |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR) at End of Intravenous Treatment (EOIV) Visit: Clinically Evaluable (CE) Analysis Set at EOIV |
NCT02497781 (29) [back to overview] | Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Analysis Set at LFU |
NCT02497781 (29) [back to overview] | Change From Baseline in Pulse Rate at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Plasma Concentrations of Ceftazidime and Avibactam |
NCT02497781 (29) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT02497781 (29) [back to overview] | Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters |
NCT02497781 (29) [back to overview] | Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Microbiological Response: Microbiologically Evaluable (ME) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Combined Response: Microbiological Intent-to-treat (Micro-ITT) Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR) at End of 72 Hours Treatment: Clinically Evaluable (CE) Analysis Set at 72 Hours |
NCT02497781 (29) [back to overview] | Percentage of Participants With Emergent Infections: Microbiologically Evaluable (ME) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Analysis Set at LFU |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR): Microbiologically Evaluable (ME) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR): Microbiological ITT (Micro-ITT) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Favourable Clinical Response (CR): Intent-to-treat (ITT) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit |
NCT02497781 (29) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Percentage of Participants With Creatinine Clearance (CrCl) at Day 7 |
NCT02497781 (29) [back to overview] | Percentage of Participants With Combined Response: Microbiologically Evaluable (ME) Analysis Population |
NCT02497781 (29) [back to overview] | Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs) |
NCT02497781 (29) [back to overview] | Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Treatment (EOIV) Visit |
NCT02497781 (29) [back to overview] | Change From Baseline in Respiratory Rate at End of Intravenous Treatment (EOIV) Visit |
NCT02504827 (2) [back to overview] | Peak Sputum Concentration |
NCT02504827 (2) [back to overview] | Peak Plasma Concentration (Cmax) |
NCT02822950 (5) [back to overview] | Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients |
NCT02822950 (5) [back to overview] | Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients |
NCT02822950 (5) [back to overview] | Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients |
NCT02822950 (5) [back to overview] | Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients |
NCT02822950 (5) [back to overview] | Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients |
NCT03978091 (40) [back to overview] | Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax) |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)] |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)] |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)] |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)] |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)] |
NCT03978091 (40) [back to overview] | Concentration of Study Drug at Steady State After Continuous Infusion (Css) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug After the First Dose (Cmax) |
NCT03978091 (40) [back to overview] | Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss) |
NCT03978091 (40) [back to overview] | Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level |
NCT03978091 (40) [back to overview] | Total Body Plasma Clearance of Study Drug (CL) |
NCT03978091 (40) [back to overview] | Total Body Plasma Clearance of Study Drug (CL) |
NCT03978091 (40) [back to overview] | Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss) |
NCT03978091 (40) [back to overview] | Total Body Plasma Clearance of Study Drug (CL) |
NCT03978091 (40) [back to overview] | Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax) |
NCT03978091 (40) [back to overview] | Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC] |
NCT03978091 (40) [back to overview] | Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax) |
NCT03978091 (40) [back to overview] | Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)] |
NCT03978091 (40) [back to overview] | Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax) |
NCT03978091 (40) [back to overview] | Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax) |
NCT03978091 (40) [back to overview] | Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax) |
NCT03978091 (40) [back to overview] | Renal Clearance of Study Drug (CLR) |
NCT03978091 (40) [back to overview] | Renal Clearance of Study Drug (CLR) |
NCT03978091 (40) [back to overview] | Renal Clearance of Study Drug (CLR) |
NCT03978091 (40) [back to overview] | Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event |
NCT03978091 (40) [back to overview] | Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin) |
NCT03978091 (40) [back to overview] | Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin) |
NCT03978091 (40) [back to overview] | Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug After the First Dose (Cmax) |
NCT03978091 (40) [back to overview] | Maximum Plasma Concentration of Study Drug After the First Dose (Cmax) |
NCT03978091 (40) [back to overview] | Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax) |
NCT03978091 (40) [back to overview] | Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC] |
NCT03978091 (40) [back to overview] | Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss) |
NCT03978091 (40) [back to overview] | Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC] |
NCT03978091 (40) [back to overview] | Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax) |
NCT03978091 (40) [back to overview] | Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax) |
NCT03978091 (40) [back to overview] | Concentration of Study Drug at Steady State After Continuous Infusion (Css) |
NCT04358991 (1) [back to overview] | Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients |
NCT04486625 (29) [back to overview] | Time for Cmax (Tmax) of ATM |
NCT04486625 (29) [back to overview] | Tmax of AVI |
NCT04486625 (29) [back to overview] | Total Daily Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours at Steady-state (AUC0-24,ss) of Aztreonam (ATM) |
NCT04486625 (29) [back to overview] | Vss of AVI |
NCT04486625 (29) [back to overview] | Vz of AVI |
NCT04486625 (29) [back to overview] | Ae0-tau of AVI |
NCT04486625 (29) [back to overview] | Ae0-tau% of AVI |
NCT04486625 (29) [back to overview] | Apparent Volume of Distribution (Vz) of ATM |
NCT04486625 (29) [back to overview] | Apparent Volume of Distribution at Steady-state (Vss) of ATM |
NCT04486625 (29) [back to overview] | Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval)(AUC0-tau) of ATM |
NCT04486625 (29) [back to overview] | AUC0-24,ss of Avibactam (AVI) |
NCT04486625 (29) [back to overview] | AUC0-tau of AVI |
NCT04486625 (29) [back to overview] | CL of AVI |
NCT04486625 (29) [back to overview] | Clearance (CL) of ATM |
NCT04486625 (29) [back to overview] | CLr of AVI |
NCT04486625 (29) [back to overview] | Cmax of AVI |
NCT04486625 (29) [back to overview] | Ctau of AVI |
NCT04486625 (29) [back to overview] | Cumulative Amount of Drug Recovered Unchanged in Urine up to Time Tau (Ae0-tau) of ATM |
NCT04486625 (29) [back to overview] | Maximum Plasma Concentration (Cmax) of ATM |
NCT04486625 (29) [back to overview] | Observed Plasma Concentration at the End of the Dosing Interval (Tau) (Ctau) of ATM |
NCT04486625 (29) [back to overview] | Percent of Dose Recovered Unchanged in Urine up to Time Tau (Ae0-tau%) of ATM |
NCT04486625 (29) [back to overview] | Renal Clearance (CLr) of ATM |
NCT04486625 (29) [back to overview] | t1/2 of AVI |
NCT04486625 (29) [back to overview] | Terminal Elimination Half-life (t1/2) of ATM |
NCT04486625 (29) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All-causality) |
NCT04486625 (29) [back to overview] | Number of Participants With TEAEs (Treatment-related) |
NCT04486625 (29) [back to overview] | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
NCT04486625 (29) [back to overview] | Number of Participants With Categorical Post-Baseline Vital Signs Data |
NCT04486625 (29) [back to overview] | Number of Participants With Abnormal Electrocardiogram (ECG) |
NCT04973826 (34) [back to overview] | Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam |
NCT04973826 (34) [back to overview] | Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam |
NCT04973826 (34) [back to overview] | Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Number of Participants With Abnormal Vital Signs |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Clearance (CL) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Clearance (CL) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Number of Participants With Abnormal Electrocardiograms (ECGs) |
NCT04973826 (34) [back to overview] | Number of Participants With Abnormal Laboratory Assessments |
NCT04973826 (34) [back to overview] | Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam |
NCT04973826 (34) [back to overview] | Number of Participants With an Adverse Event (AE) |
NCT04973826 (34) [back to overview] | Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Renal Clearance (CLr) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam |
NCT04973826 (34) [back to overview] | Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam |
NCT04973826 (34) [back to overview] | Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam |
NCT04973826 (34) [back to overview] | Renal Clearance (CLr) on Day 1 & 4 of Aztreonam |
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 1 |
Imipenem Cilastatin | 0 |
[back to top]
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 19 |
Imipenem Cilastatin | 25 |
[back to top]
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 24 |
Imipenem Cilastatin | 32 |
[back to top]
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 20 |
Imipenem Cilastatin | 24 |
[back to top]
Clinical Outcome in CE Patients at the TOC Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 24 |
Imipenem Cilastatin | 29 |
[back to top]
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 28 |
Imipenem Cilastatin | 36 |
[back to top]
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 1 |
Imipenem Cilastatin | 0 |
[back to top]
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 1 |
Imipenem Cilastatin | 0 |
[back to top]
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 1 |
Imipenem Cilastatin | 0 |
[back to top]
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 1 |
[back to top]
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 1 |
[back to top]
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 15 |
Imipenem Cilastatin | 17 |
[back to top]
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 19 |
Imipenem Cilastatin | 23 |
[back to top]
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 0 |
[back to top]
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 0 |
[back to top]
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 1 |
[back to top]
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 1 |
[back to top]
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: 5 to 9 days post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 0 |
Imipenem Cilastatin | 1 |
[back to top]
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL (NCT00690378)
Timeframe: End of IV therapy (4 to 14 days)
Intervention | Participants (Number) |
---|
NXL104/CAZ | 25 |
Imipenem Cilastatin | 34 |
[back to top]
Microbiological Outcome in ME Patients at the LFU Visit
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL (NCT00690378)
Timeframe: 4 to 6 weeks post-therapy
Intervention | Participants (Number) |
---|
NXL104/CAZ | 15 |
Imipenem Cilastatin | 18 |
[back to top]
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline. (NCT00752219)
Timeframe: End of IV therapy: From Day 5 to Day 14
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 66 |
Meropenem | 74 |
[back to top]
Number of Participants With Clinical Response at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline. (NCT00752219)
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 62 |
Meropenem | 71 |
[back to top]
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline. (NCT00752219)
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 62 |
Meropenem | 71 |
[back to top]
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. (NCT00752219)
Timeframe: End of IV therapy: From Day 5 to Day 14
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 84 |
Meropenem | 87 |
[back to top]
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. (NCT00752219)
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 79 |
Meropenem | 84 |
[back to top]
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. (NCT00752219)
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 80 |
Meropenem | 85 |
[back to top]
Number of Participants With Microbiological Response at the End of IV Therapy
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline. (NCT00752219)
Timeframe: End of IV therapy: From Day 5 to Day 14
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 66 |
Meropenem | 74 |
[back to top]
Number of Participants With Microbiological Response at the Test of Cure Visit
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline. (NCT00752219)
Timeframe: Test of cure visit: 2 weeks post-therapy (Day 28)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 62 |
Meropenem | 71 |
[back to top]
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state. (NCT00752219)
Timeframe: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Intervention | participants (Number) |
---|
| AEs | SAEs |
---|
Meropenem | 59 | 11 |
,NXL104/Ceftazidime + Metronidazole | 65 | 9 |
[back to top]
Number of Participants With Microbiological Response at the Late Follow-up Visit
Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment) (NCT00752219)
Timeframe: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Intervention | participants (Number) |
---|
NXL104/Ceftazidime + Metronidazole | 62 |
Meropenem | 71 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=179, 194) | Klebsiella pneumoniae - Favorable (n=30, 35) | Proteus mirabilis - Favorable (n=11,5) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=8, 13) |
---|
CAZ-AVI | 129 | 23 | 11 | 5 | 6 |
,Doripenem | 127 | 18 | 1 | 8 | 8 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 198 | 32 | 16 | 6 | 9 |
,Doripenem | 189 | 30 | 6 | 9 | 13 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=19, 18) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 19 | 2 | 1 | 0 |
,Doripenem | 17 | 1 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=19, 18) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 19 | 2 | 1 | 0 |
,Doripenem | 17 | 1 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 29 | 3 | 1 | 1 |
,Doripenem | 27 | 2 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=4,4) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | E. coli (MIC: 1) - Favorable (n=2, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=4,5) | P.aeruginosa (MIC: 4) - Favorable (n=5,6) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | P.aeruginosa (MIC: 16) - Favorable (n=0,1) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=1,0) |
---|
CAZ-AVI | 2 | 5 | 17 | 83 | 56 | 13 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 4 | 7 | 1 | 4 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 0 | 1 |
,Doripenem | 4 | 5 | 17 | 94 | 40 | 8 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 | 6 | 2 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | 4 | 1 | 1 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=4,4) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | E. coli (MIC: 1) - Favorable (n=2, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=4,4) | P.aeruginosa (MIC: 4) - Favorable (n=3,4) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=0,0) |
---|
CAZ-AVI | 2 | 5 | 17 | 83 | 56 | 13 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 4 | 7 | 1 | 4 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 0 | 0 |
,Doripenem | 4 | 5 | 17 | 94 | 40 | 8 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 | 6 | 2 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 3 | 0 | 0 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=5, 6) | E. coli (MIC: 0.015) - Favorable (n=8, 7) | E. coli (MIC: 0.03) - Favorable (n=28, 35) | E. coli (MIC: 0.06) - Favorable (n=123, 139) | E. coli (MIC: 0.12) - Favorable (n=90, 81) | E. coli (MIC: 0.25) - Favorable (n=28, 25) | E. coli (MIC: 0.5) - Favorable (n=5, 6) | E. coli (MIC: 1) - Favorable (n=3, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16) | Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1) | Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5) | Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 2,5) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,2) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=5,5) | P.aeruginosa (MIC: 4) - Favorable (n=7,6) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | P.aeruginosa (MIC: 16) - Favorable (n=1,1) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=2,0) |
---|
CAZ-AVI | 3 | 8 | 24 | 103 | 67 | 18 | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 7 | 9 | 1 | 6 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 10 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 3 | 1 | 0 | 0 | 2 |
,Doripenem | 5 | 6 | 23 | 111 | 54 | 13 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 7 | 3 | 11 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 5 | 4 | 1 | 1 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1,1) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | E. coli (MIC: 0.12) - Favorable (n=1, 2) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | E. coli (MIC: 0.5) - Favorable (n=0, 0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=0,2) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | P.aeruginosa (MIC: >16) - Favorable (n=1,1) |
---|
CAZ-AVI | 1 | 106 | 64 | 7 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 12 | 7 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 4 | 6 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
,Doripenem | 1 | 95 | 70 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 18 | 6 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 1 | 2 | 0 | 1 | 1 | 1 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1,1) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | E. coli (MIC: 0.12) - Favorable (n=1,2) | E. coli (MIC: 0.25) - Favorable (n=1,0) | E. coli (MIC: 0.5) - Favorable (n=0,0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=0,0) | P.aeruginosa (MIC: 8) - Favorable (n=0,0) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | P.aeruginosa (MIC: >16) - Favorable (n=0,0) |
---|
CAZ-AVI | 1 | 106 | 64 | 7 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 12 | 7 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 4 | 6 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,Doripenem | 1 | 95 | 70 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 18 | 6 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1, 3) | E. coli (MIC: 0.015) - Favorable (n=160, 160) | E. coli (MIC: 0.03) - Favorable (n=112, 123) | E. coli (MIC: 0.06) - Favorable (n=14, 10) | E. coli (MIC: 0.12) - Favorable (n=3, 3) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | E. coli (MIC: 0.5) - Favorable (n=0,0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3) | Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27) | Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4) | Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5) | Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1) | Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=2,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,5) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=2,2) | P.aeruginosa (MIC: 8) - Favorable (n=2,1) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | P.aeruginosa (MIC: >16) - Favorable (n=2,1) |
---|
CAZ-AVI | 1 | 127 | 89 | 10 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 16 | 10 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 5 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 2 | 0 | 1 | 1 | 1 | 0 | 2 |
,Doripenem | 3 | 119 | 86 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 21 | 7 | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 2 | 1 | 3 | 0 | 1 | 1 | 1 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=214, 226) | Klebsiella pneumoniae - Favorable (n=32, 42) | Proteus mirabilis - Favorable (n=14, 7) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=13, 18) |
---|
CAZ-AVI | 180 | 26 | 14 | 5 | 8 |
,Doripenem | 176 | 29 | 4 | 8 | 13 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=214, 221) | Klebsiella pneumoniae - Favorable (n=31, 41) | Proteus mirabilis - Favorable (n=14, 7) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=9, 13) |
---|
CAZ-AVI | 180 | 25 | 14 | 5 | 7 |
,Doripenem | 171 | 28 | 4 | 8 | 9 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 229 | 33 | 16 | 6 | 12 |
,Doripenem | 220 | 35 | 9 | 9 | 15 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=22, 20) | Klebsiella pneumoniae - Favorable (n=2, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 22 | 2 | 1 | 0 |
,Doripenem | 20 | 2 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=22, 20) | Klebsiella pneumoniae - Favorable (n=2, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 22 | 2 | 1 | 0 |
,Doripenem | 20 | 2 | 0 | 1 |
[back to top]
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 235 | 19 |
,Doripenem | 254 | 33 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 335 | 1 |
,Doripenem | 369 | 2 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 324 | 1 |
,Doripenem | 359 | 2 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 374 | 1 | 18 |
,Doripenem | 395 | 3 | 19 |
[back to top]
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 184 | 67 |
,Doripenem | 173 | 99 |
[back to top]
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 182 | 63 |
,Doripenem | 166 | 96 |
[back to top]
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 268 | 83 | 42 |
,Doripenem | 254 | 125 | 38 |
[back to top]
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 243 | 49 |
,Doripenem | 236 | 75 |
[back to top]
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 241 | 45 |
,Doripenem | 225 | 73 |
[back to top]
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 304 | 58 | 31 |
,Doripenem | 296 | 83 | 38 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 37 | 14 |
,Doripenem | 41 | 22 |
[back to top]
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 6587.2 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 47 | 19 | 9 |
,Doripenem | 51 | 27 | 6 |
[back to top]
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 123 | 122 | 1 |
,Doripenem | 118 | 113 | 5 |
[back to top]
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 124 | 124 | 0 |
,Doripenem | 111 | 108 | 3 |
[back to top]
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 124 | 124 | 0 |
,Doripenem | 108 | 105 | 3 |
[back to top]
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01595438)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 157 | 155 | 2 |
,Doripenem | 150 | 143 | 7 |
[back to top]
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 1883.2 |
[back to top]
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 9307.3 |
[back to top]
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 30 to 90 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 47575.1 |
[back to top]
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: Between 300 to 360 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 16959.6 |
[back to top]
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01595438)
Timeframe: within 15 minutes before/after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 65481.2 |
[back to top]
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 280 | 81 | 32 |
,Doripenem | 269 | 109 | 39 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 346 | 4 |
,Doripenem | 387 | 4 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 327 | 4 | 5 |
,Doripenem | 368 | 2 | 1 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 318 | 4 | 3 |
,Doripenem | 358 | 2 | 1 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 378 | 5 | 10 |
,Doripenem | 407 | 5 | 5 |
[back to top]
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 232 | 15 | 4 |
,Doripenem | 246 | 24 | 2 |
[back to top]
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 226 | 15 | 4 |
,Doripenem | 236 | 24 | 2 |
[back to top]
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 335 | 23 | 35 |
,Doripenem | 350 | 39 | 28 |
[back to top]
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 289 | 8 |
,Doripenem | 309 | 21 |
[back to top]
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 283 | 4 | 5 |
,Doripenem | 298 | 13 | 0 |
[back to top]
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 277 | 4 | 5 |
,Doripenem | 285 | 13 | 0 |
[back to top]
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 355 | 11 | 27 |
,Doripenem | 377 | 24 | 16 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=51, 63) | Escherichia coli patients - Clin cure (n=23, 27) | Klebsiella pneumoniae patients-Clin cure(n=15, 23) | Pseudomonas aeruginosa patients-Clin cure(n=3,6) | Enterobacter cloacae patients-Clin cure(n=5,5) | Proteus mirabilis patients - Clin cure (n=0, 2) |
---|
CAZ-AVI | 50 | 22 | 15 | 3 | 5 | 0 |
,Doripenem | 61 | 25 | 23 | 6 | 5 | 2 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 31 | 3 | 1 | 1 |
,Doripenem | 28 | 2 | 0 | 2 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=48, 57) | Escherichia coli patients-Clin cure (n=23,27) | Klebsiella pneumoniae patients-Clin cure(n=14, 22) | Pseudomonas aeruginosa patients-Clin cure(n=1, 2) | Enterobacter cloacae patients-Clin cure(n=5,5) | Proteus mirabilis patients - Clin cure (n=0, 2) |
---|
CAZ-AVI | 47 | 22 | 14 | 1 | 5 | 0 |
,Doripenem | 55 | 25 | 22 | 2 | 5 | 2 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=75, 84) | Escherichia coli patients - Clin cure (n=36, 37) | Klebsiella pneumoniae patients-Clin cure(n=18,30) | Pseudomonas aeruginosa patients- Clin cure(n=7,6) | Enterobacter cloacae patients-Clin cure(n=7,6) | Proteus mirabilis patients - Clin cure (n=2, 5) |
---|
CAZ-AVI | 67 | 33 | 17 | 5 | 5 | 2 |
,Doripenem | 75 | 31 | 28 | 6 | 5 | 5 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01595438)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 35 | 13 |
,Doripenem | 37 | 20 |
[back to top]
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01595438)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
Intervention | Participants (Number) |
---|
| Symptomatic resolution | Symptom persistence | Indeterminate |
---|
CAZ-AVI | 276 | 103 | 14 |
,Doripenem | 276 | 124 | 17 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=250, 274) | Klebsiella pneumoniae - Favorable (n=34, 49) | Proteus mirabilis - Favorable (n=13, 11) | Enterobacter cloacae - Favorable (n= 9, 12) | Pseudomonas aeruginosa - Favorable (n=18, 18) |
---|
CAZ-AVI | 250 | 34 | 13 | 9 | 17 |
,Doripenem | 274 | 48 | 11 | 12 | 17 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=249, 270) | Klebsiella pneumoniae - Favorable (n=33, 48) | Proteus mirabilis - Favorable (n=13,11) | Enterobacter cloacae - Favorable (n= 9, 12) | Pseudomonas aeruginosa - Favorable (n=10, 15) |
---|
CAZ-AVI | 249 | 33 | 13 | 9 | 9 |
,Doripenem | 270 | 47 | 11 | 12 | 14 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 280 | 41 | 16 | 9 | 17 |
,Doripenem | 293 | 51 | 11 | 13 | 18 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=26, 24) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 26 | 1 | 1 | 1 |
,Doripenem | 24 | 1 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01595438)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=26, 24) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 26 | 1 | 1 | 1 |
,Doripenem | 24 | 1 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01595438)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 31 | 2 | 1 | 1 |
,Doripenem | 28 | 2 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01595438)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=179, 198) | Klebsiella pneumoniae - Favorable (n=31, 36) | Proteus mirabilis - Favorable (n=11,5) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=12, 16) |
---|
CAZ-AVI | 129 | 24 | 11 | 5 | 7 |
,Doripenem | 131 | 19 | 1 | 8 | 9 |
[back to top]
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 243 | 49 |
,Doripenem | 236 | 75 |
[back to top]
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 241 | 45 |
,Doripenem | 225 | 73 |
[back to top]
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 304 | 58 | 31 |
,Doripenem | 296 | 83 | 38 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 37 | 14 |
,Doripenem | 41 | 22 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 35 | 13 |
,Doripenem | 37 | 20 |
[back to top]
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 47 | 19 | 9 |
,Doripenem | 51 | 27 | 6 |
[back to top]
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 123 | 122 | 1 |
,Doripenem | 118 | 113 | 5 |
[back to top]
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 124 | 124 | 0 |
,Doripenem | 111 | 108 | 3 |
[back to top]
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 124 | 124 | 0 |
,Doripenem | 108 | 105 | 3 |
[back to top]
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. (NCT01599806)
Timeframe: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Intervention | Participants (Number) |
---|
| Number of patients with fever (>38°C) at baseline | Number afebrile at the time of the last obs | Number censored at the time of the last obs |
---|
CAZ-AVI | 157 | 155 | 2 |
,Doripenem | 150 | 143 | 7 |
[back to top]
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 65481.2 |
[back to top]
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 6587.2 |
[back to top]
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 1883.2 |
[back to top]
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: within 15 minutes before/after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 9307.3 |
[back to top]
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 30 to 90 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 47575.1 |
[back to top]
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. (NCT01599806)
Timeframe: Between 300 to 360 minutes after dose
Intervention | NG/ML (Geometric Mean) |
---|
CAZ-AVI | 16959.6 |
[back to top]
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 280 | 81 | 32 |
,Doripenem | 269 | 109 | 39 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 346 | 4 |
,Doripenem | 387 | 4 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 327 | 4 | 5 |
,Doripenem | 368 | 2 | 1 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 318 | 4 | 3 |
,Doripenem | 358 | 2 | 1 |
[back to top]
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 378 | 5 | 10 |
,Doripenem | 407 | 5 | 5 |
[back to top]
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 235 | 19 |
,Doripenem | 254 | 33 |
[back to top]
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 232 | 15 | 4 |
,Doripenem | 246 | 24 | 2 |
[back to top]
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 226 | 15 | 4 |
,Doripenem | 236 | 24 | 2 |
[back to top]
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 335 | 23 | 35 |
,Doripenem | 350 | 39 | 28 |
[back to top]
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 289 | 8 |
,Doripenem | 309 | 21 |
[back to top]
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 283 | 4 | 5 |
,Doripenem | 298 | 13 | 0 |
[back to top]
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 277 | 4 | 5 |
,Doripenem | 285 | 13 | 0 |
[back to top]
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 355 | 11 | 27 |
,Doripenem | 377 | 24 | 16 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=51, 63) | Escherichia coli patients - Clin cure (n=23, 27) | Klebsiella pneumoniae patients-Clin cure(n=15, 23) | Pseudomonas aeruginosa patients-Clin cure(n=3,6) | Enterobacter cloacae patients-Clin cure(n=5,5) | Proteus mirabilis patients - Clin cure (n=0, 2) |
---|
CAZ-AVI | 50 | 22 | 15 | 3 | 5 | 0 |
,Doripenem | 61 | 25 | 23 | 6 | 5 | 2 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=48, 57) | Escherichia coli patients-Clin cure (n=23,27) | Klebsiella pneumoniae patients-Clin cure(n=14, 22) | Pseudomonas aeruginosa patients-Clin cure(n=1, 2) | Enterobacter cloacae patients-Clin cure(n=5,5) | Proteus mirabilis patients - Clin cure (n=0, 2) |
---|
CAZ-AVI | 47 | 22 | 14 | 1 | 5 | 0 |
,Doripenem | 55 | 25 | 22 | 2 | 5 | 2 |
[back to top]
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participants (Number) |
---|
| All patients - Clinical cure (n=75, 84) | Escherichia coli patients - Clin cure (n=36, 37) | Klebsiella pneumoniae patients-Clin cure(n=18,30) | Pseudomonas aeruginosa patients- Clin cure(n=7,6) | Enterobacter cloacae patients-Clin cure(n=7,6) | Proteus mirabilis patients - Clin cure (n=2, 5) |
---|
CAZ-AVI | 67 | 33 | 17 | 5 | 5 | 2 |
,Doripenem | 75 | 31 | 28 | 6 | 5 | 5 |
[back to top]
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). (NCT01599806)
Timeframe: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
Intervention | Participants (Number) |
---|
| Symptomatic resolution | Symptom persistence | Indeterminate |
---|
CAZ-AVI | 276 | 103 | 14 |
,Doripenem | 276 | 124 | 17 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=250, 274) | Klebsiella pneumoniae - Favorable (n=34, 49) | Proteus mirabilis - Favorable (n=13, 11) | Enterobacter cloacae - Favorable (n= 9, 12) | Pseudomonas aeruginosa - Favorable (n=18, 18) |
---|
CAZ-AVI | 250 | 34 | 13 | 9 | 17 |
,Doripenem | 274 | 48 | 11 | 12 | 17 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=249, 270) | Klebsiella pneumoniae - Favorable (n=33, 48) | Proteus mirabilis - Favorable (n=13,11) | Enterobacter cloacae - Favorable (n= 9, 12) | Pseudomonas aeruginosa - Favorable (n=10, 15) |
---|
CAZ-AVI | 249 | 33 | 13 | 9 | 9 |
,Doripenem | 270 | 47 | 11 | 12 | 14 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 280 | 41 | 16 | 9 | 17 |
,Doripenem | 293 | 51 | 11 | 13 | 18 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=26, 24) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 26 | 1 | 1 | 1 |
,Doripenem | 24 | 1 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=26, 24) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 26 | 1 | 1 | 1 |
,Doripenem | 24 | 1 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 31 | 2 | 1 | 1 |
,Doripenem | 28 | 2 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=179, 198) | Klebsiella pneumoniae - Favorable (n=31, 36) | Proteus mirabilis - Favorable (n=11,5) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=12, 16) |
---|
CAZ-AVI | 129 | 24 | 11 | 5 | 7 |
,Doripenem | 131 | 19 | 1 | 8 | 9 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=179, 194) | Klebsiella pneumoniae - Favorable (n=30, 35) | Proteus mirabilis - Favorable (n=11,5) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=8, 13) |
---|
CAZ-AVI | 129 | 23 | 11 | 5 | 6 |
,Doripenem | 127 | 18 | 1 | 8 | 8 |
[back to top]
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 198 | 32 | 16 | 6 | 9 |
,Doripenem | 189 | 30 | 6 | 9 | 13 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=19, 18) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 19 | 2 | 1 | 0 |
,Doripenem | 17 | 1 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=19, 18) | Klebsiella pneumoniae - Favorable (n=2, 1) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 19 | 2 | 1 | 0 |
,Doripenem | 17 | 1 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 29 | 3 | 1 | 1 |
,Doripenem | 27 | 2 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=4,4) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | E. coli (MIC: 1) - Favorable (n=2, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=4,5) | P.aeruginosa (MIC: 4) - Favorable (n=5,6) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | P.aeruginosa (MIC: 16) - Favorable (n=0,1) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=1,0) |
---|
CAZ-AVI | 2 | 5 | 17 | 83 | 56 | 13 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 4 | 7 | 1 | 4 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 0 | 1 |
,Doripenem | 4 | 5 | 17 | 94 | 40 | 8 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 | 6 | 2 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | 4 | 1 | 1 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=4,4) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | E. coli (MIC: 1) - Favorable (n=2, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=4,4) | P.aeruginosa (MIC: 4) - Favorable (n=3,4) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=0,0) |
---|
CAZ-AVI | 2 | 5 | 17 | 83 | 56 | 13 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 4 | 7 | 1 | 4 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 1 | 0 | 0 | 0 |
,Doripenem | 4 | 5 | 17 | 94 | 40 | 8 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 | 6 | 2 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 3 | 0 | 0 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=5, 6) | E. coli (MIC: 0.015) - Favorable (n=8, 7) | E. coli (MIC: 0.03) - Favorable (n=28, 35) | E. coli (MIC: 0.06) - Favorable (n=123, 139) | E. coli (MIC: 0.12) - Favorable (n=90, 81) | E. coli (MIC: 0.25) - Favorable (n=28, 25) | E. coli (MIC: 0.5) - Favorable (n=5, 6) | E. coli (MIC: 1) - Favorable (n=3, 0) | E. coli (MIC: 2) - Favorable (n=1, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: 32) - Favorable (n=0, 0) | E. coli (MIC: >32) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16) | Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1) | Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5) | Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2) | Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | Entero. cloacae (MIC: 1)- Favorable (n= 2,5) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,2) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=5,5) | P.aeruginosa (MIC: 4) - Favorable (n=7,6) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | P.aeruginosa (MIC: 16) - Favorable (n=1,1) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | P.aeruginosa (MIC: >32) - Favorable (n=2,0) |
---|
CAZ-AVI | 3 | 8 | 24 | 103 | 67 | 18 | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 7 | 9 | 1 | 6 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 10 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 3 | 1 | 0 | 0 | 2 |
,Doripenem | 5 | 6 | 23 | 111 | 54 | 13 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 7 | 3 | 11 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 5 | 4 | 1 | 1 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1,1) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | E. coli (MIC: 0.12) - Favorable (n=1, 2) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | E. coli (MIC: 0.5) - Favorable (n=0, 0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=0,2) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | P.aeruginosa (MIC: >16) - Favorable (n=1,1) |
---|
CAZ-AVI | 1 | 106 | 64 | 7 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 12 | 7 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 4 | 6 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
,Doripenem | 1 | 95 | 70 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 18 | 6 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 1 | 2 | 0 | 1 | 1 | 1 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1,1) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | E. coli (MIC: 0.12) - Favorable (n=1,2) | E. coli (MIC: 0.25) - Favorable (n=1,0) | E. coli (MIC: 0.5) - Favorable (n=0,0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=0,0) | P.aeruginosa (MIC: 8) - Favorable (n=0,0) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | P.aeruginosa (MIC: >16) - Favorable (n=0,0) |
---|
CAZ-AVI | 1 | 106 | 64 | 7 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 12 | 7 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 4 | 6 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,Doripenem | 1 | 95 | 70 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 18 | 6 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=1, 3) | E. coli (MIC: 0.015) - Favorable (n=160, 160) | E. coli (MIC: 0.03) - Favorable (n=112, 123) | E. coli (MIC: 0.06) - Favorable (n=14, 10) | E. coli (MIC: 0.12) - Favorable (n=3, 3) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | E. coli (MIC: 0.5) - Favorable (n=0,0) | E. coli (MIC: 1) - Favorable (n=0, 0) | E. coli (MIC: 2) - Favorable (n=0, 0) | E. coli (MIC: 4) - Favorable (n=0, 0) | E. coli (MIC: 8) - Favorable (n=0, 0) | E. coli (MIC: 16) - Favorable (n=0, 0) | E. coli (MIC: >16) - Favorable (n=0, 0) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3) | Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27) | Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4) | Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5) | Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1) | Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | P.aeruginosa (MIC: 0.12) - Favorable (n=2,2) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,5) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | P.aeruginosa (MIC: 4) - Favorable (n=2,2) | P.aeruginosa (MIC: 8) - Favorable (n=2,1) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | P.aeruginosa (MIC: >16) - Favorable (n=2,1) |
---|
CAZ-AVI | 1 | 127 | 89 | 10 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 16 | 10 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 5 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 2 | 0 | 1 | 1 | 1 | 0 | 2 |
,Doripenem | 3 | 119 | 86 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 21 | 7 | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 2 | 1 | 3 | 0 | 1 | 1 | 1 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=214, 226) | Klebsiella pneumoniae - Favorable (n=32, 42) | Proteus mirabilis - Favorable (n=14, 7) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=13, 18) |
---|
CAZ-AVI | 180 | 26 | 14 | 5 | 8 |
,Doripenem | 176 | 29 | 4 | 8 | 13 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=214, 221) | Klebsiella pneumoniae - Favorable (n=31, 41) | Proteus mirabilis - Favorable (n=14, 7) | Enterobacter cloacae - Favorable (n= 7, 11) | Pseudomonas aeruginosa - Favorable (n=9, 13) |
---|
CAZ-AVI | 180 | 25 | 14 | 5 | 7 |
,Doripenem | 171 | 28 | 4 | 8 | 9 |
[back to top]
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=292, 306) | Klebsiella pneumoniae - Favorable (n=44, 56) | Proteus mirabilis - Favorable (n=17, 13) | Enterobacter cloacae - Favorable (n= 11,13) | Pseudomonas aeruginosa - Favorable (n=18, 20) |
---|
CAZ-AVI | 229 | 33 | 16 | 6 | 12 |
,Doripenem | 220 | 35 | 9 | 9 | 15 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=22, 20) | Klebsiella pneumoniae - Favorable (n=2, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 22 | 2 | 1 | 0 |
,Doripenem | 20 | 2 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=22, 20) | Klebsiella pneumoniae - Favorable (n=2, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=0, 1) |
---|
CAZ-AVI | 22 | 2 | 1 | 0 |
,Doripenem | 20 | 2 | 0 | 1 |
[back to top]
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only (NCT01599806)
Timeframe: At TOC visit. TOC visit is 21 to 25 days from Randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=32, 28) | Klebsiella pneumoniae - Favorable (n=4, 2) | Proteus mirabilis - Favorable (n=1, 0) | Pseudomonas aeruginosa - Favorable (n=1, 2) |
---|
CAZ-AVI | 31 | 3 | 1 | 1 |
,Doripenem | 28 | 2 | 0 | 2 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 335 | 1 |
,Doripenem | 369 | 2 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 324 | 1 |
,Doripenem | 359 | 2 |
[back to top]
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV) (NCT01599806)
Timeframe: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 374 | 1 | 18 |
,Doripenem | 395 | 3 | 19 |
[back to top]
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 184 | 67 |
,Doripenem | 173 | 99 |
[back to top]
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 182 | 63 |
,Doripenem | 166 | 96 |
[back to top]
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU (NCT01599806)
Timeframe: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Intervention | Participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 268 | 83 | 42 |
,Doripenem | 254 | 125 | 38 |
[back to top]
Per-patient Microbiological Response at EOT in EME at EOT Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 9 | 0 |
,cUTI:Best Available Therapy | 127 | 0 |
,cUTI:CAZ-AVI | 133 | 1 |
[back to top]
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 | 2 |
,cUTI:Best Available Therapy | 129 | 2 | 6 |
,cUTI:CAZ-AVI | 132 | 2 | 10 |
[back to top]
Clinical Response at FU2 in EME at FU2 Analysis Set
Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure |
---|
cUTI:Best Available Therapy | 102 | 12 |
,cUTI:CAZ-AVI | 106 | 10 |
[back to top]
Clinical Response at FU1 in EME at FU1 Analysis Set.
Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 7 | 0 |
,cUTI:Best Available Therapy | 110 | 8 |
,cUTI:CAZ-AVI | 120 | 4 |
[back to top]
Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
cUTI:Best Available Therapy | 118 | 13 | 6 |
,cUTI:CAZ-AVI | 123 | 11 | 10 |
[back to top]
Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| E. coli - Clinical cure (n=6, 4, 57, 59) | K. pneumoniae - Clinical cure (n=3, 5, 65, 55) | P. aeruginosa - clinical cure (n=1, 1, 5, 14) |
---|
cIAI:Best Available Therapy | 2 | 2 | 1 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 3 | 1 |
,cUTI:Best Available Therapy | 54 | 61 | 5 |
,cUTI:CAZ-AVI | 53 | 54 | 12 |
[back to top]
Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 | 2 |
,cUTI:Best Available Therapy | 121 | 8 | 8 |
,cUTI:CAZ-AVI | 127 | 5 | 12 |
[back to top]
Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 9 | 0 |
,cUTI:Best Available Therapy | 127 | 0 |
,cUTI:CAZ-AVI | 134 | 0 |
[back to top]
Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 9 | 0 | 1 |
,cUTI:Best Available Therapy | 136 | 0 | 1 |
,cUTI:CAZ-AVI | 142 | 0 | 2 |
[back to top]
Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| At least 1 failed - Clin. cure (n=4,7,12,7) | Antibiotics - Clin. cure (n=0,1,0,0) | Carbapenems - Clin. cure (n=1,0,1,2) | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | Fluoroquinolones - Clin. cure (n=1,2,7,1) | Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0) | Imidazole Derivatives - Clin. cure (n=2,3,0,0) | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | Other Antibacterials-Clin. cure (n=0,1,1,0) | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2) |
---|
cIAI:Best Available Therapy | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
,cIAI:CAZ-AVI + Metronidazole | 7 | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 1 | 4 |
,cUTI:Best Available Therapy | 12 | 0 | 1 | 2 | 0 | 1 | 2 | 7 | 0 | 0 | 1 | 1 | 1 | 0 | 3 |
,cUTI:CAZ-AVI | 6 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
[back to top]
Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration. (NCT01644643)
Timeframe: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Intervention | NG/ML (Geometric Mean) |
---|
CAZ (1) | 23880.3 |
AVI (1) | 3061.3 |
CAZ (2) | 39465.3 |
AVI (2) | 6304.1 |
CAZ (3) | 14904.8 |
AVI (3) | 1769.3 |
[back to top]
The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set
Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. (NCT01644643)
Timeframe: From first infusion to Day 28
Intervention | Participant (Number) |
---|
| All cause mortality | Deaths due to disease progression | Number of patients with any AE withoutcome=death |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 0 | 0 | 0 |
,cUTI:Best Available Therapy | 1 | 0 | 1 |
,cUTI:CAZ-AVI | 1 | 0 | 1 |
[back to top]
The Reason for Treatment Change/Discontinuation in mMITT Analysis Set
Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl) (NCT01644643)
Timeframe: From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Treatment Change | Treatment Change - Crcl change | Treatment Change - Other | Treatment discontinuation | Treatment discontinuation - AE | Treatment discontinuation - Other | Treatment interrupted | Treatment interrupted - Change of infusion site |
---|
cIAI:Best Available Therapy | 1 | 1 | 0 | 4 | 1 | 3 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,cUTI:Best Available Therapy | 8 | 5 | 3 | 3 | 1 | 2 | 0 | 0 |
,cUTI:CAZ-AVI | 11 | 10 | 1 | 1 | 1 | 0 | 1 | 1 |
[back to top]
Per-patient Microbiological Response at TOC in mMITT Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 | 2 |
,cUTI:Best Available Therapy | 88 | 42 | 7 |
,cUTI:CAZ-AVI | 118 | 17 | 9 |
[back to top]
Per-patient Microbiological Response at TOC in EME at TOC Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 |
,cUTI:Best Available Therapy | 84 | 40 |
,cUTI:CAZ-AVI | 114 | 17 |
[back to top]
Per-patient Microbiological Response at FU2 in mMITT Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
cUTI:Best Available Therapy | 73 | 54 | 10 |
,cUTI:CAZ-AVI | 99 | 35 | 10 |
[back to top]
Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable |
---|
cUTI:Best Available Therapy | 68 | 47 |
,cUTI:CAZ-AVI | 85 | 32 |
[back to top]
Per-patient Microbiological Response at FU1 in mMITT Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 | 2 |
,cUTI:Best Available Therapy | 78 | 50 | 9 |
,cUTI:CAZ-AVI | 103 | 29 | 12 |
[back to top]
Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 7 | 0 |
,cUTI:Best Available Therapy | 75 | 45 |
,cUTI:CAZ-AVI | 98 | 28 |
[back to top]
Per-patient Microbiological Response at EOT in mMITT Analysis Set
"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
cIAI:Best Available Therapy | 6 | 0 | 5 |
,cIAI:CAZ-AVI + Metronidazole | 9 | 0 | 1 |
,cUTI:Best Available Therapy | 130 | 1 | 6 |
,cUTI:CAZ-AVI | 136 | 1 | 7 |
[back to top]
Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Antibiotics - Clin. cure (n=0,1,0,0) | Carbapenems - Clin. cure (n=0,0,1,1) | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | Fluoroquinolones - Clin. cure (n=0,2,5,1) | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | Other Antibacterials-Clin. cure (n=0,1,1,0) | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
,cIAI:CAZ-AVI + Metronidazole | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 3 | 0 | 1 | 0 | 1 | 4 |
,cUTI:Best Available Therapy | 0 | 1 | 2 | 0 | 1 | 2 | 5 | 0 | 0 | 1 | 1 | 0 | 2 |
,cUTI:CAZ-AVI | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=6, 4, 57, 59) | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) |
---|
cIAI:Best Available Therapy | 2 | 0 | 4 | 2 | 0 | 1 | 1 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 1 | 3 | 0 | 2 | 1 | 0 | 0 |
,cUTI:Best Available Therapy | 38 | 16 | 3 | 43 | 19 | 3 | 3 | 2 | 0 |
,cUTI:CAZ-AVI | 52 | 3 | 4 | 46 | 8 | 1 | 11 | 2 | 1 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=2, 3, 49, 53) | Escherichia coli - Unfavorable (n=2, 3, 49, 53) | Kleb. pneumoniae - Favorable (n=2, 3, 60, 53) | Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13) |
---|
cIAI:Best Available Therapy | 2 | 0 | 2 | 0 | 1 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 3 | 0 | 1 | 0 |
,cUTI:Best Available Therapy | 34 | 15 | 42 | 18 | 3 | 2 |
,cUTI:CAZ-AVI | 50 | 3 | 45 | 8 | 11 | 2 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32. (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2) | E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20) | E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16) | E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11) | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0) | K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5) | K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6) | K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22) | K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18) | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0) | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5) |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,cUTI:Best Available Therapy | 1 | 0 | 3 | 12 | 10 | 5 | 1 | 2 | 2 | 1 | 6 | 7 | 16 | 11 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
,cUTI:CAZ-AVI | 1 | 1 | 2 | 16 | 15 | 10 | 2 | 1 | 4 | 0 | 4 | 5 | 19 | 16 | 1 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 3 | 4 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32. (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1) | E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18) | E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15) | E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9) | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0) | K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5) | K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6) | K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21) | K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17) | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4) |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,cUTI:Best Available Therapy | 1 | 0 | 3 | 10 | 9 | 4 | 1 | 2 | 2 | 0 | 6 | 7 | 16 | 11 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
,cUTI:CAZ-AVI | 1 | 1 | 1 | 16 | 15 | 9 | 2 | 1 | 4 | 0 | 4 | 5 | 19 | 15 | 2 | 0 | 0 | 1 | 1 | 2 | 0 | 3 | 4 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=0, 0, 57, 59) | Escherichia coli - Unfavorable (n=0, 0, 57, 59) | Escherichia coli - Indeterminate (n=0, 0, 57, 59) | Kleb. pneumoniae - Favorable (n=0, 0, 65, 55) | Kleb. pneumoniae - Unfavorable (n=0, 0, 65, 55) | Kleb. pneumoniae - Indeterminate (n=0, 0, 65, 55) | Pseudo. aeruginosa - Favorable (n=0, 0, 5, 14) | Pseudo. aeruginosa - Unfavorable (n=0, 0, 5, 14) | Pseudo. aeruginosa - Indeterminate (n=0, 0, 5, 14) |
---|
cUTI:Best Available Therapy | 32 | 19 | 6 | 35 | 26 | 4 | 2 | 3 | 0 |
,cUTI:CAZ-AVI | 43 | 14 | 2 | 39 | 14 | 2 | 10 | 2 | 2 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=44, 50) | Escherichia coli - Unfavorable (n=44, 50) | Kleb. pneumoniae - Favorable (n= 56, 46) | Kleb. pneumoniae - Unfavorable (n=56, 46) | Pseudo. aeruginosa - Favorable (n=4, 11) | Pseudo. aeruginosa - Unfavorable (n=4, 11) |
---|
cUTI:Best Available Therapy | 28 | 16 | 33 | 23 | 2 | 2 |
,cUTI:CAZ-AVI | 39 | 11 | 32 | 14 | 9 | 2 |
[back to top]
The 28 Days All Cause Mortality Rate in mMITT Analysis Set
Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. (NCT01644643)
Timeframe: From first infusion to Day 28
Intervention | Participant (Number) |
---|
| All cause mortality | Deaths due to disease progression | Number of patients with any AE with outcome=death |
---|
cIAI:Best Available Therapy | 1 | 0 | 1 |
,cIAI:CAZ-AVI + Metronidazole | 0 | 0 | 0 |
,cUTI:Best Available Therapy | 3 | 0 | 3 |
,cUTI:CAZ-AVI | 3 | 0 | 3 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=6, 4, 57, 59) | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) |
---|
cIAI:Best Available Therapy | 2 | 0 | 4 | 2 | 0 | 1 | 1 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 1 | 3 | 0 | 2 | 1 | 0 | 0 |
,cUTI:Best Available Therapy | 33 | 18 | 6 | 39 | 23 | 3 | 3 | 2 | 0 |
,cUTI:CAZ-AVI | 45 | 12 | 2 | 42 | 10 | 3 | 8 | 2 | 4 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=2, 3, 46, 54) | Escherichia coli - Unfavorable (n=2, 3, 46, 54) | Kleb. pneumoniae - Favorable (n=2, 2, 59, 50) | Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10) |
---|
cIAI:Best Available Therapy | 2 | 0 | 2 | 0 | 1 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 2 | 0 | 1 | 0 |
,cUTI:Best Available Therapy | 30 | 16 | 38 | 21 | 3 | 2 |
,cUTI:CAZ-AVI | 43 | 11 | 40 | 10 | 8 | 2 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=6, 4, 57, 59) | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) |
---|
cIAI:Best Available Therapy | 2 | 0 | 4 | 2 | 0 | 1 | 1 | 0 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 1 | 4 | 0 | 1 | 1 | 0 | 0 |
,cUTI:Best Available Therapy | 53 | 0 | 4 | 61 | 1 | 3 | 5 | 0 | 0 |
,cUTI:CAZ-AVI | 57 | 0 | 2 | 52 | 0 | 3 | 14 | 0 | 0 |
[back to top]
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Escherichia coli - Favorable (n=2, 3, 51, 55) | Escherichia coli - Unfavorable (n=2, 3, 51, 55) | Kleb. pneumoniae - Favorable (n=2, 4, 60, 52) | Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52) | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) |
---|
cIAI:Best Available Therapy | 2 | 0 | 2 | 0 | 1 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 0 | 4 | 0 | 1 | 0 |
,cUTI:Best Available Therapy | 51 | 0 | 60 | 0 | 5 | 0 |
,cUTI:CAZ-AVI | 55 | 0 | 52 | 0 | 14 | 0 |
[back to top]
Clinical Response at TOC in EME at TOC Analysis Set.
Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Clinical cure | Clinical failure |
---|
cIAI:Best Available Therapy | 5 | 0 |
,cIAI:CAZ-AVI + Metronidazole | 8 | 0 |
,cUTI:Best Available Therapy | 120 | 2 |
,cUTI:CAZ-AVI | 126 | 2 |
[back to top]
Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| E. coli - Clinical cure (n=2, 3, 48, 52) | K. pneumoniae - Clinical cure (n=2, 3, 59, 53) | P. aeruginosa - Clinical cure (n=1, 1, 5, 12) |
---|
cIAI:Best Available Therapy | 2 | 2 | 1 |
,cIAI:CAZ-AVI + Metronidazole | 3 | 3 | 1 |
,cUTI:Best Available Therapy | 47 | 59 | 5 |
,cUTI:CAZ-AVI | 51 | 53 | 12 |
[back to top]
Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set
Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. (NCT01644643)
Timeframe: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Intervention | Participant (Number) |
---|
| Carbapenems - Clin. cure (n=1,0) | Comb of Sulf/Trime inc Deriv-Clin. cure(n=1,0) | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=0,2) | Cortico,Po. Comb W/Antibio.-Clin. cure(n=1,0) | First-Gen. Cephalosporins-Clin. cure (n=2,0) | Fluoroquinolones - Clin. cure (n=5,0) | Other Aminoglycosides-Clin. cure (n=0,1) | Other Antibacterials-Clin. cure (n=1,0) | Other Antibio. F. Topic. Use-Clin. cure(n=1,0) | Third-Gen.Cephalosporins -Clin. cure(n=1,1) |
---|
cUTI:Best Available Therapy | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 0 | 1 | 0 |
,cUTI:CAZ-AVI | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
[back to top]
Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set
Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Intervention | Participant (Number) |
---|
| Antibiotics - Clin. cure (n=0,1,0,0) | Carbapenems - Clin. cure (n=0,0,1,1) | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0) | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | Fluoroquinolones - Clin. cure (n=0,2,5,1) | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | Other Antibacterials-Clin. cure (n=0,1,1,0) | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2) |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
,cIAI:CAZ-AVI + Metronidazole | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 3 | 0 | 1 | 0 | 1 | 4 |
,cUTI:Best Available Therapy | 0 | 1 | 1 | 0 | 0 | 2 | 4 | 0 | 0 | 1 | 1 | 0 | 0 |
,cUTI:CAZ-AVI | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
[back to top]
Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set
Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). (NCT01644643)
Timeframe: 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Intervention | Participant (Number) |
---|
| Antibiotics - Clin. cure (n=0,1,0,0) | Carbapenems - Clin. cure (n=0,0,1,1) | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | Fluoroquinolones - Clin. cure (n=0,2,5,1) | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | Other Antibacterials-Clin. cure (n=0,1,1,0) | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) |
---|
cIAI:Best Available Therapy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
,cIAI:CAZ-AVI + Metronidazole | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 3 | 0 | 1 | 0 | 1 | 4 |
,cUTI:Best Available Therapy | 0 | 1 | 2 | 0 | 1 | 2 | 5 | 0 | 1 | 1 | 1 | 0 | 2 |
,cUTI:CAZ-AVI | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
[back to top]
Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration. (NCT01644643)
Timeframe: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Intervention | NG/ML (Geometric Mean) |
---|
CAZ (1) | 74260.2 |
AVI (1) | 10103.8 |
CAZ (2) | 56905.9 |
AVI (2) | 8141.2 |
CAZ (3) | 21442.0 |
AVI (3) | 2425.0 |
[back to top]
Safety Profile - Number of Subjects With at Least 1 AE
from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C. (NCT01689207)
Timeframe: Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)
Intervention | Participants (Number) |
---|
| Number of subjects with at least 1 AE | Subjects with at least 1 AE with outcome of death | At least 1 AE leading to discontinuation |
---|
Part A: ATM 2000mg + AVI 600mg | 0 | 0 | 0 |
,Part A: Avibactam (AVI) 600mg | 2 | 0 | 1 |
,Part A: Aztreonam (ATM) 2000mg | 0 | 0 | 0 |
,Part A: Drug | 2 | 0 | 1 |
,Part A: Placebo | 1 | 0 | 0 |
,Part B: Cohort 1 Drug | 4 | 0 | 0 |
,Part B: Cohort 2 Drug | 2 | 0 | 2 |
,Part B: Cohort 3 Drug | 6 | 0 | 1 |
,Part B: Cohort 4 Drug | 8 | 0 | 0 |
,Part B: Cohort 5 Drug | 3 | 0 | 0 |
,Part B: Placebo | 3 | 0 | 0 |
,Part C: Cohort 1 Drug | 5 | 0 | 0 |
,Part C: Cohort 2 Drug | 7 | 0 | 0 |
,Part C: Placebo | 3 | 0 | 1 |
[back to top]
PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL). (NCT01689207)
Timeframe: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
Intervention | ug*h/mL (Geometric Mean) |
---|
| AUC (ug*h/mL) - Aztreonam (ATM) alone | AUC (ug*h/mL) - Avibactam (AVI)alone | AUC (ug*h/mL) - ATM in combination (Day 1) | AUCss (ug*h/mL) - ATM in combination | AUC (ug*h/mL) - AVI in combination (Day 1) | AUCss (ug*h/mL) - AVI in combination |
---|
Part A: Drug | 372 | 52.6 | 375 | NA | 58.3 | NA |
,Part A: Placebo | NA | NA | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | 345 | 275 | 31.8 | 26.1 |
,Part B: Cohort 2 Drug | NA | NA | 326 | NA | 47.8 | NA |
,Part B: Cohort 3 Drug | NA | NA | 283 | 231 | 53.1 | 43.3 |
,Part B: Cohort 4 Drug | NA | NA | 270 | 223 | 35.7 | 29.0 |
,Part B: Cohort 5 Drug | NA | NA | 250 | 203 | 31.4 | 26.7 |
,Part B: Placebo | NA | NA | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | 276 | 211 | 41.9 | 29.3 |
,Part C: Cohort 2 Drug | NA | NA | 308 | 259 | 52.3 | 38.8 |
,Part C: Placebo | NA | NA | NA | NA | NA | NA |
[back to top]
PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion. (NCT01689207)
Timeframe: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
Intervention | ug/mL (Geometric Mean) |
---|
| Cmax (ug/mL) - ATM alone | Cmax (ug/mL) - AVI alone | Cmax (ug/mL) - ATM in combination (Day1) | Css, max (ug/mL) - ATM in combination | Cmax (ug/mL) - AVI in combination (Day1) | Css, max (ug/mL) - AVI in combination |
---|
Part A: Drug | 143 | 26.8 | 137 | NA | 137 | NA |
,Part A: Placebo | NA | NA | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | 123 | 124 | 16.0 | 14.5 |
,Part B: Cohort 2 Drug | NA | NA | 123 | NA | 25.1 | NA |
,Part B: Cohort 3 Drug | NA | NA | 82.4 | 80.9 | 19.3 | 17.6 |
,Part B: Cohort 4 Drug | NA | NA | 63.2 | 62.6 | 9.99 | 8.69 |
,Part B: Cohort 5 Drug | NA | NA | 59.2 | 55.7 | 8.68 | 8.36 |
,Part B: Placebo | NA | NA | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | 75.6 | 57.2 | 12.1 | 8.88 |
,Part C: Cohort 2 Drug | NA | NA | 81.6 | 66.2 | 15.2 | 11.6 |
,Part C: Placebo | NA | NA | NA | NA | NA | NA |
[back to top]
PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion. (NCT01689207)
Timeframe: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
Intervention | h (Geometric Mean) |
---|
| t1/2 (h) - Aztreonam (ATM) alone | t1/2 (h) - Avibactam (AVI)alone | t1/2 (h) - ATM in combination | t1/2 (h) - AVI in combination |
---|
Part A: Drug | 1.98 | 2.22 | 2.09 | 2.35 |
,Part A: Placebo | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | 2.24 | 2.17 |
,Part B: Cohort 2 Drug | NA | NA | 1.98 | 2.82 |
,Part B: Cohort 3 Drug | NA | NA | 1.90 | 2.61 |
,Part B: Cohort 4 Drug | NA | NA | 2.14 | 2.26 |
,Part B: Cohort 5 Drug | NA | NA | 2.28 | 1.85 |
,Part B: Placebo | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | NA | NA |
,Part C: Cohort 2 Drug | NA | NA | NA | NA |
,Part C: Placebo | NA | NA | NA | NA |
[back to top]
PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C
Time to Cmax (tmax) (NCT01689207)
Timeframe: Day 1
Intervention | (h) (Median) |
---|
| tmax (h) - ATM alone | tmax (h) - AVI alone | tmax (h) - ATM in combination (Day 1) | tmax (h) - AVI in combination (Day 1) |
---|
Part A: Drug | 0.98 | 0.98 | 0.98 | 0.98 |
,Part A: Placebo | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | 0.98 | 0.98 |
,Part B: Cohort 2 Drug | NA | NA | 0.98 | 0.98 |
,Part B: Cohort 3 Drug | NA | NA | 1.98 | 1.98 |
,Part B: Cohort 4 Drug | NA | NA | 2.98 | 2.98 |
,Part B: Cohort 5 Drug | NA | NA | 2.98 | 2.50 |
,Part B: Placebo | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | 2.98 | 2.98 |
,Part C: Cohort 2 Drug | NA | NA | 2.98 | 2.98 |
,Part C: Placebo | NA | NA | NA | NA |
[back to top]
PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Volume of distribution at steady state (Vss). (NCT01689207)
Timeframe: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
Intervention | L (Geometric Mean) |
---|
| Vss (L) - ATM alone | Vss (L) - AVI alone | Vss (L) - ATM in comination | Vss (L) - AVI in comination |
---|
Part A: Drug | 13.4 | 20.1 | 13.8 | 19.0 |
,Part A: Placebo | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | 15.4 | 22.8 |
,Part B: Cohort 2 Drug | NA | NA | 15.1 | 22.2 |
,Part B: Cohort 3 Drug | NA | NA | 12.5 | 20.0 |
,Part B: Cohort 4 Drug | NA | NA | 13.7 | 23.5 |
,Part B: Cohort 5 Drug | NA | NA | 15.6 | 25.2 |
,Part B: Placebo | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | NA | NA |
,Part C: Cohort 2 Drug | NA | NA | NA | NA |
,Part C: Placebo | NA | NA | NA | NA |
[back to top]
PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion. (NCT01689207)
Timeframe: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
Intervention | L/h (Geometric Mean) |
---|
| CL (L/h) - ATM alone | CL(L/h) - AVI alone | CLr (L/h) - ATM alone | CLr (L/h) - AVI alone | CL(L/h) - ATM in combination (Day 1) | CLr (L/h) - ATM in comination (Day 1) | CL(L/h) - AVI in combination (Day 1) | CLr (L/h) - AVI in comination (Day 1) | CL(L/h) - ATM in combination (Steady state) | CLr (L/h) - ATM in comination (Steady state) | CL(L/h) - AVI in combination (Steady state) | CLr (L/h) - AVI in comination (Steady state) |
---|
Part A: Drug | 5.37 | 11.4 | 3.93 | 9.77 | 5.33 | 3.78 | 10.3 | 8.71 | NA | NA | NA | NA |
,Part A: Placebo | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,Part B: Cohort 1 Drug | NA | NA | NA | NA | 5.79 | 4.04 | 11.8 | 10.6 | 7.27 | 4.66 | 14.3 | 12.4 |
,Part B: Cohort 2 Drug | NA | NA | NA | NA | 6.15 | 4.10 | 12.5 | 10.9 | NA | NA | NA | NA |
,Part B: Cohort 3 Drug | NA | NA | NA | NA | 5.29 | 4.18 | 11.3 | 11.1 | 6.49 | 4.93 | 13.8 | 13.9 |
,Part B: Cohort 4 Drug | NA | NA | NA | NA | 5.56 | 4.09 | 12.6 | 11.9 | 6.72 | 5.07 | 15.5 | 14.7 |
,Part B: Cohort 5 Drug | NA | NA | NA | NA | 5.99 | 4.43 | 13.1 | 12.5 | 7.39 | 5.25 | 15.4 | 14.5 |
,Part B: Placebo | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
,Part C: Cohort 1 Drug | NA | NA | NA | NA | NA | 4.22 | NA | 10.8 | 7.10 | 4.97 | 14.0 | 13.0 |
,Part C: Cohort 2 Drug | NA | NA | NA | NA | NA | 3.41 | NA | 7.78 | 5.79 | 3.99 | 10.6 | 9.49 |
,Part C: Placebo | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=70, 80) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 30) | Pseudomonas aeruginosa (n=14, 18) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 69 | 5 | 21 | 14 |
,Meropenem | 78 | 5 | 29 | 16 |
[back to top]
Safety and Tolerability:ECG , QTcB and QTcF Intervals
Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline. (NCT01726023)
Timeframe: EOT visit/any observation on treatment
Intervention | Number of patients (Number) |
---|
| Normal to Abnormal: EOT | Normal to Abnormal: Anytime up to EOT | Reaching a value in QT: ≥450 (ms) | Reaching a value in QT: ≥480 (ms) | Reaching a value in QT: ≥500 (ms) | QT: ≥500 and increase from Baseline ≥60(ms) | Increase in QT: ≥30 (ms) | Increase in QT: ≥60 (ms) | Decrease in QT: ≥30 (ms) | Decrease in QT: ≥60 (ms) | Reaching a value in QTcB: ≥450(ms) | Reaching a value in QTcB: ≥480(ms) | Reaching a value in QTcB: ≥500 (ms) | QTcB: ≥500 and increase from Baseline ≥60(ms) | Increase in QTcB: ≥30 (ms) | Increase in QTcB: ≥60 (ms) | Decrease in QTcB: ≥30 (ms) | Decrease in QTcB: ≥60 (ms) | Reaching a value in QTcF: ≥450 (ms) | Reaching a value in QTcF: ≥480 (ms) | Reaching a value in QTcF: ≥500 (ms) | QTcF: ≥500 and increase from Baseline ≥60 (ms) | Increase in QTcF: ≥30 (ms) | Increase in QTcF: ≥60 (ms) | Decrease QTcF: ≥30 (ms) | Decrease QTcF: ≥60 (ms) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 17 | 34 | 9 | 2 | 0 | 0 | 115 | 50 | 24 | 12 | 57 | 13 | 4 | 2 | 21 | 2 | 42 | 6 | 19 | 4 | 1 | 0 | 42 | 4 | 21 | 7 |
,Meropenem | 14 | 30 | 10 | 1 | 0 | 0 | 114 | 44 | 24 | 4 | 63 | 8 | 2 | 1 | 27 | 1 | 26 | 4 | 18 | 0 | 0 | 0 | 41 | 3 | 19 | 1 |
[back to top]
Safety and Tolerability: Clinical Laboratory Evaluation Hematology.
Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set) (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)
Intervention | Number of patients (Number) |
---|
| Platelet count: PCS (Low) | Platelet count: PCS (High) | Red blood cell count: PCS (Low) | Red blood cell count: PCS (High) | White blood cell: PCS (Low) | White blood cell: PCS (High) | Hemoglobin: PCS (Low) | Hemoglobin: PCS (High) | Lymphocytes: PCS (Low) | Lymphocytes: PCS (High) | Neutrophils: PCS (Low) | Neutrophils: PCS (High) | Eosinophils: PCS (High) | Monocytes: PCS (High) | Basophils: PCS (High) | Direct Coombs test:- at Baseline, + post-Baseline | Hematocrit (ratio): PCS (Low) | Hematocrit (ratio): PCS (High) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 1 | 5 | 7 | 0 | 1 | 4 | 7 | 0 | 1 | 0 | 4 | 9 | 0 | 0 | 0 | 15 | 5 | 0 |
,Meropenem | 1 | 4 | 13 | 0 | 1 | 5 | 14 | 0 | 1 | 1 | 2 | 8 | 0 | 0 | 0 | 2 | 8 | 0 |
[back to top]
Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.
Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set) (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)
Intervention | Number of patients (Number) |
---|
| Alanine aminotransferase (μkat/L): PCS (High) | Alkaline phosphatase (μkat/L): PCS (Low) | Alkaline phosphatase (μkat/L): PCS (High) | Aspartate aminotransferase (μkat/L): PCS (High) | Bicarbonate (mmol/L) PCS (Low) | Bicarbonate (mmol/L): PCS (High) | Creatinine (μmol/L): PCS (High) | Glucose (non-fasting) (mmol/L): PCS (Low) | Glucose (non-fasting) (mmol/L): PCS (High) | Gamma-glutamyl transferase (μkat/L):PCS (High) | Inorganic phosphorus (mmol/L): PCS (Low) | Inorganic phosphorus (mmol/L): PCS (High) | Potassium (mmol/L): PCS (Low) | Potassium (mmol/L): PCS (High) | Total bilirubin (μmol/L): PCS (High) | Direct bilirubin (μmol/L): PCS (High) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 3 | 0 | 2 | 4 | 1 | 0 | 0 | 0 | 1 | 2 | 3 | 0 | 9 | 3 | 0 | 1 |
,Meropenem | 8 | 0 | 3 | 4 | 0 | 0 | 1 | 0 | 1 | 4 | 7 | 0 | 5 | 1 | 1 | 1 |
[back to top]
Safety and Tolerability by Incidence: Extent of Exposure.
Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day. (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)
Intervention | Number of patients (Number) |
---|
| 1 - 2 days | 3 - 4 days | 5 -10 days | 11 - 14 days | >14 days |
---|
Ceftazidime-Avibactam Plus Metronidazole | 10 | 6 | 175 | 24 | 0 |
,Meropenem | 5 | 5 | 181 | 26 | 0 |
[back to top]
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 103 | 3 |
,Meropenem | 113 | 5 |
[back to top]
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At late follow up (LFU) visits (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 157 | 11 |
,Meropenem | 168 | 11 |
[back to top]
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 90 | 7 |
,Meropenem | 106 | 6 |
[back to top]
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 116 | 10 | 17 |
,Meropenem | 132 | 9 | 11 |
[back to top]
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 89 | 7 |
,Meropenem | 100 | 6 |
[back to top]
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the test of cure visit (Day 28 to35)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 166 | 11 |
,Meropenem | 173 | 11 |
[back to top]
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 93 | 7 |
,Meropenem | 113 | 6 |
[back to top]
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 119 | 10 | 14 |
,Meropenem | 135 | 9 | 8 |
[back to top]
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 92 | 7 |
,Meropenem | 107 | 6 |
[back to top]
Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.
Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42). (NCT01726023)
Timeframe: study duration (from screening to Day 49 LFU visit)
Intervention | Number of patients (Number) |
---|
| Any AE | Any SAE | Any AE leading to discontinuation of IP | Any AE of severe intensity | Total number of deaths | Deaths due to disease progression | Any AE with outcome=death |
---|
Ceftazidime-Avibactam Plus Metronidazole | 82 | 9 | 7 | 5 | 2 | 2 | 0 |
,Meropenem | 83 | 11 | 3 | 5 | 1 | 0 | 1 |
[back to top]
The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.
Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever. (NCT01726023)
Timeframe: while on study therapy (from Day 1 to Day 14)
Intervention | Days (Median) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 1 |
Meropenem | 2 |
[back to top]
The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.
Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever. (NCT01726023)
Timeframe: while on study therapy (from Day 1 to Day 14)
Intervention | Days (Median) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 1 |
Meropenem | 1.5 |
[back to top]
Plasma Concentrations for Ceftazidime and Avibactam
Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations (NCT01726023)
Timeframe: At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.
Intervention | ng/mL (Geometric Mean) |
---|
Ceftazidime(1) | 60300.4 |
Avibactam(1) | 10126.9 |
Ceftazidime(2) | 46473.9 |
Avibactam(2) | 7289.3 |
Ceftazidime(3) | 9555.0 |
Avibactam(3) | 1207.2 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=69, 77) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 29) | Pseudomonas aeruginosa (n=14, 16) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 68 | 5 | 21 | 14 |
,Meropenem | 75 | 5 | 28 | 14 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=84, 89) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=28,35) | Pseudomonas aeruginosa (n=17, 20) | Streptococcus anginosus grou (n=8, 7) | Streptococcus mitis group (n=6, 5) | Enterococcus faecalis (n=6, 6) | Enterococcus faecium (n=4, 7) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 77 | 5 | 22 | 15 | 7 | 6 | 5 | 4 |
,Meropenem | 86 | 5 | 32 | 17 | 6 | 5 | 5 | 5 |
[back to top]
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 126 | 6 | 11 |
,Meropenem | 140 | 7 | 5 |
[back to top]
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 104 | 3 |
,Meropenem | 120 | 5 |
[back to top]
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Clinical cure | Clinical failure |
---|
Ceftazidime-Avibactam Plus Metronidazole | 183 | 7 |
,Meropenem | 187 | 9 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 92 | 7 |
,Meropenem | 107 | 6 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 119 | 10 | 14 |
,Meropenem | 135 | 9 | 8 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 89 | 7 |
,Meropenem | 100 | 6 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 116 | 10 | 17 |
,Meropenem | 132 | 9 | 11 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 90 | 7 |
,Meropenem | 106 | 6 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 103 | 3 |
,Meropenem | 113 | 5 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 126 | 6 | 11 |
,Meropenem | 140 | 7 | 5 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the end of treatment (EOT) (within 24 hours after last IV dose)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 104 | 3 |
,Meropenem | 120 | 5 |
[back to top]
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.
"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 22 | 1 |
,Meropenem | 23 | 1 |
[back to top]
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
Ceftazidime-Avibactam Plus Metronidazole | 24 | 1 | 4 |
,Meropenem | 27 | 1 | 1 |
[back to top]
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 93 | 7 |
,Meropenem | 113 | 6 |
[back to top]
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.
"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)." (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Number of patients (Number) |
---|
| Favorable | Unfavorable |
---|
Ceftazidime-Avibactam Plus Metronidazole | 22 | 1 |
,Meropenem | 25 | 1 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=84, 89) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=28,35) | Pseudomonas aeruginosa (n=17, 20) | Streptococcus anginosus group (n=8, 7) | Streptococcus mitis group (n=6, 5) | Enterococcus faecalis (n=6, 6) | Enterococcus faecium (n=4, 7) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 70 | 5 | 23 | 14 | 7 | 6 | 6 | 4 |
,Meropenem | 84 | 5 | 31 | 17 | 5 | 5 | 4 | 5 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=84, 89) | Klebsiella pneumoniae (n=28, 35) | Pseudomonas aeruginosa (n=17, 20) | Klebsiella oxytoca (n=5, 5) | Enterococcus faecalis (n=6, 6) | Enterococcus faecium (n=4, 7) | Streptococcus anginosus group (n=8, 7) | Streptococcus mitis group (n=6, 5) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 70 | 22 | 14 | 4 | 4 | 3 | 7 | 6 |
,Meropenem | 82 | 31 | 17 | 5 | 4 | 5 | 5 | 5 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=69, 77) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 29) | Pseudomonas aeruginosa (n=14, 16) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 64 | 5 | 21 | 13 |
,Meropenem | 74 | 5 | 28 | 14 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the test of cure (TOC) (Day 28 to 35)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=70, 80) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 30) | Pseudomonas aeruginosa (n=14, 18) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 65 | 5 | 21 | 13 |
,Meropenem | 77 | 5 | 29 | 16 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=69, 77) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 29) | Pseudomonas aeruginosa (n=14, 16) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 63 | 4 | 21 | 13 |
,Meropenem | 72 | 5 | 27 | 14 |
[back to top]
The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. (NCT01726023)
Timeframe: At the late follow up (LFU) (Day 42 to 49)
Intervention | Participants with favorable responses (Number) |
---|
| Escherichia coli (n=70, 80) | Klebsiella oxytoca (n=5, 5) | Klebsiella pneumoniae (n=22, 30) | Pseudomonas aeruginosa (n=14, 18) |
---|
Ceftazidime-Avibactam Plus Metronidazole | 64 | 4 | 21 | 13 |
,Meropenem | 75 | 5 | 28 | 16 |
[back to top]
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 245 | 79 | 32 |
,Meropenem | 270 | 70 | 30 |
[back to top]
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 96 | 29 |
,Meropenem | 103 | 28 |
[back to top]
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 85 | 22 |
,Meropenem | 94 | 24 |
[back to top]
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 120 | 37 | 14 |
,Meropenem | 138 | 34 | 12 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| All (n=45, 54) | Enterobacteriaceae (n=34, 41) | Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 6) | Escherichia coli (n=6, 5) | Klebsiella pneumoniae (n=20, 30) | Gram- pathogens not Enterobacteriaceae (n=11,16) | Pseudomonas aeruginosa (n=11, 15) |
---|
CAZ-AVI | 40 | 32 | 3 | 6 | 5 | 20 | 8 | 8 |
,Meropenem | 45 | 33 | 2 | 4 | 3 | 26 | 14 | 13 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| All (n=32, 40) | Enterobacteriaceae (n=28, 35) | Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 5) | Escherichia coli (n=5, 4) | Klebsiella pneumoniae (n=16, 26) | Gram- pathogens not Enterobacteriaceae (n=4,7) | Pseudomonas aeruginosa (n=4, 6) |
---|
CAZ-AVI | 31 | 27 | 3 | 6 | 5 | 16 | 4 | 4 |
,Meropenem | 36 | 31 | 2 | 3 | 3 | 25 | 7 | 6 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| All (n=36, 41) | Enterobacteriaceae (n=27, 30) | Enterobacter cloacae (n=5, 5) | Escherichia coli (n=5, 4) | Klebsiella pneumoniae (n=14, 22) | Gram- pathogens not Enterobacteriaceae (n=9,13) | Pseudomonas aeruginosa (n=9, 13) |
---|
CAZ-AVI | 29 | 23 | 5 | 4 | 12 | 6 | 6 |
,Meropenem | 32 | 22 | 3 | 3 | 17 | 12 | 12 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| All (n=45, 54) | Enterobacteriaceae (n=34, 41) | Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 6) | Escherichia coli (n=6, 5) | Klebsiella pneumoniae (n=20, 30) | Gram- pathogens not Enterobacteriaceae (n=11,16) | Pseudomonas aeruginosa (n=11, 15) |
---|
CAZ-AVI | 35 | 28 | 3 | 6 | 4 | 16 | 7 | 7 |
,Meropenem | 40 | 29 | 2 | 4 | 3 | 22 | 13 | 13 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| All (n=29, 32) | Enterobacteriaceae (n=26, 28) | Enterobacter cloacae (n=5, 5) | Escherichia coli (n=4, 4) | Klebsiella pneumoniae (n=14, 20) | Gram- pathogens not Enterobacteriaceae (n=3,6) | Pseudomonas aeruginosa (n=3, 6) |
---|
CAZ-AVI | 25 | 23 | 5 | 4 | 12 | 2 | 2 |
,Meropenem | 26 | 22 | 3 | 3 | 17 | 6 | 6 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 29 | 10 | 19 | 316 | 11 |
,Meropenem | 25 | 6 | 19 | 341 | 4 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 16 | 6 | 10 | 153 | 2 |
,Meropenem | 14 | 5 | 9 | 170 | 0 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 11 | 5 | 6 | 245 | 1 |
,Meropenem | 8 | 4 | 4 | 262 | 0 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 30 | 10 | 20 | 315 | 11 |
,Meropenem | 27 | 6 | 21 | 339 | 4 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 17 | 6 | 11 | 152 | 2 |
,Meropenem | 16 | 5 | 11 | 168 | 0 |
[back to top]
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28. (NCT01808092)
Timeframe: at Day 28 from randomization
Intervention | participants (Number) |
---|
| Number of patients who died (all cause mortality) | Deaths due to disease progression | Number of patients with any AE with outcome=death | Number of patients alive | Number of patients with unknown survival status |
---|
CAZ-AVI | 12 | 5 | 7 | 244 | 1 |
,Meropenem | 9 | 4 | 5 | 261 | 0 |
[back to top]
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| All (n=39, 49) | Enterobacteriaceae (n=29, 37) | Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 5) | Escherichia coli (n=6, 4) | Klebsiella pneumoniae (n=16, 28) | Gram- pathogens not Enterobacteriaceae (n=10,14) | Pseudomonas aeruginosa (n=10, 13) |
---|
CAZ-AVI | 35 | 27 | 3 | 6 | 5 | 16 | 8 | 8 |
,Meropenem | 42 | 31 | 2 | 3 | 3 | 25 | 13 | 12 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 31 | 9 |
,Meropenem | 36 | 13 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 26 | 7 |
,Meropenem | 29 | 11 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 35 | 10 | 1 |
,Meropenem | 39 | 13 | 2 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 23 | 14 |
,Meropenem | 21 | 20 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 21 | 9 |
,Meropenem | 18 | 14 |
[back to top]
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 27 | 16 | 3 |
,Meropenem | 27 | 23 | 4 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=6, 7) | Enterobacter cloacae (n=22, 17) | Escherichia coli (n=14, 18) | Klebsiella pneumoniae (n=46, 57) | Proteus mirabilis (n=9, 8) | Serratia marcescens (n=13, 10) | Haemophilus influenzae (n=14, 16) | Pseudomonas aeruginosa (n=50, 41) | Staphylococcus aureus (n=18, 26) |
---|
CAZ-AVI | 4 | 22 | 13 | 39 | 8 | 12 | 14 | 30 | 16 |
,Meropenem | 5 | 17 | 17 | 53 | 6 | 8 | 16 | 24 | 25 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=6, 7) | Enterobacter cloacae (n=22, 17) | Escherichia coli (n=13, 18) | Klebsiella pneumoniae (n=45, 55) | Proteus mirabilis (n=9, 8) | Serratia marcescens (n=13, 10) | Haemophilus influenzae (n=12, 15) | Pseudomonas aeruginosa (n=38, 34) | Staphylococcus aureus (n=16, 23) |
---|
CAZ-AVI | 4 | 22 | 13 | 38 | 8 | 12 | 12 | 22 | 14 |
,Meropenem | 5 | 17 | 17 | 51 | 6 | 8 | 15 | 19 | 22 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=8, 8) | Enterobacter cloacae (n=26, 22) | Escherichia coli (n=17, 20) | Klebsiella pneumoniae (n=59, 71) | Proteus mirabilis (n=14, 12) | Serratia marcescens (n=15, 13) | Haemophilus influenzae (n=16, 25) | Pseudomonas aeruginosa (n=58, 47) | Staphylococcus aureus (n=24, 34) |
---|
CAZ-AVI | 6 | 25 | 15 | 49 | 12 | 12 | 15 | 33 | 21 |
,Meropenem | 5 | 20 | 18 | 65 | 10 | 11 | 25 | 27 | 32 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=6, 5) | Enterobacter cloacae (n=21, 11) | Escherichia coli (n=11, 18) | Klebsiella pneumoniae (n=37, 49) | Proteus mirabilis (n=11, 8) | Serratia marcescens (n=12, 8) | Haemophilus influenzae (n=11, 13) | Pseudomonas aeruginosa (n=42, 35) | Staphylococcus aureus (n=14, 22) |
---|
CAZ-AVI | 5 | 18 | 10 | 29 | 9 | 9 | 11 | 18 | 5 |
,Meropenem | 3 | 7 | 16 | 39 | 6 | 5 | 12 | 14 | 17 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=6, 5) | Enterobacter cloacae (n=21, 11) | Escherichia coli (n=10, 18) | Klebsiella pneumoniae (n=37, 47) | Proteus mirabilis (n=11, 8) | Serratia marcescens (n=12, 8) | Haemophilus influenzae (n=9, 12) | Pseudomonas aeruginosa (n=31, 28) | Staphylococcus aureus (n=13, 19) |
---|
CAZ-AVI | 5 | 18 | 10 | 29 | 9 | 9 | 9 | 13 | 4 |
,Meropenem | 3 | 7 | 16 | 38 | 6 | 5 | 11 | 12 | 15 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=8, 8) | Enterobacter cloacae (n=26, 22) | Escherichia coli (n=17, 20) | Klebsiella pneumoniae (n=59, 71) | Proteus mirabilis (n=14, 12) | Serratia marcescens (n=15, 13) | Haemophilus influenzae (n=16, 25) | Pseudomonas aeruginosa (n=58, 47) | Staphylococcus aureus (n=24, 34) |
---|
CAZ-AVI | 5 | 21 | 13 | 37 | 11 | 10 | 14 | 22 | 11 |
,Meropenem | 5 | 13 | 16 | 53 | 8 | 8 | 23 | 18 | 25 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 5) | Escherichia coli (n=6, 4) | Klebsiella pneumoniae (n=16, 28) | Pseudomonas aeruginosa (n=10, 13) |
---|
CAZ-AVI | 3 | 6 | 5 | 14 | 8 |
,Meropenem | 2 | 5 | 4 | 25 | 6 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 5) | Escherichia coli (n=5, 4) | Klebsiella pneumoniae (n=16, 26) | Pseudomonas aeruginosa (n=4, 6) |
---|
CAZ-AVI | 3 | 6 | 5 | 14 | 3 |
,Meropenem | 2 | 5 | 4 | 23 | 1 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 6) | Escherichia coli (n=6, 5) | Klebsiella pneumoniae (n=20, 30) | Pseudomonas aeruginosa (n=11, 15) |
---|
CAZ-AVI | 3 | 6 | 5 | 18 | 8 |
,Meropenem | 2 | 6 | 4 | 26 | 7 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter cloacae (n=5, 5) | Escherichia coli (n=5, 4) | Klebsiella pneumoniae (n=14, 22) | Pseudomonas aeruginosa (n=9, 13) |
---|
CAZ-AVI | 4 | 4 | 11 | 3 |
,Meropenem | 4 | 4 | 14 | 3 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter cloacae (n=5, 5) | Escherichia coli (n=4, 4) | Klebsiella pneumoniae (n=14, 20) | Pseudomonas aeruginosa (n=3, 6) |
---|
CAZ-AVI | 4 | 4 | 11 | 1 |
,Meropenem | 4 | 4 | 13 | 1 |
[back to top]
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants with favorable responses (Number) |
---|
| Enterobacter aerogenes (n=4, 2) | Enterobacter cloacae (n=6, 6) | Escherichia coli (n=6, 5) | Klebsiella pneumoniae (n=20, 30) | Pseudomonas aeruginosa (n=11, 15) |
---|
CAZ-AVI | 3 | 5 | 4 | 15 | 4 |
,Meropenem | 2 | 5 | 4 | 18 | 4 |
[back to top]
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization
Intervention | participants (Number) |
---|
| Number of patients with admission date | Number of patients with at least one discharge | 1 discharge | 2 discharges | >2 discharges |
---|
CAZ-AVI | 170 | 71 | 71 | 0 | 0 |
,Meropenem | 182 | 75 | 74 | 1 | 0 |
[back to top]
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization
Intervention | participants (Number) |
---|
| Number of patients with admission date | Number of patients with at least one discharge | 1 discharge | 2 discharges | >2 discharges |
---|
CAZ-AVI | 256 | 148 | 144 | 4 | 0 |
,Meropenem | 266 | 155 | 151 | 3 | 1 |
[back to top]
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set. (NCT01808092)
Timeframe: up to 25 days from randomization
Intervention | participants (Number) |
---|
| Number of patients with admission date | Number of patients with at least one discharge | 1 discharge | 2 discharges | >2 discharges |
---|
CAZ-AVI | 355 | 206 | 201 | 5 | 0 |
,Meropenem | 366 | 206 | 200 | 4 | 2 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 112 | 31 |
,Meropenem | 123 | 28 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 96 | 26 |
,Meropenem | 112 | 26 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 128 | 38 | 5 |
,Meropenem | 148 | 31 | 5 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 80 | 45 |
,Meropenem | 89 | 42 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable |
---|
CAZ-AVI | 70 | 37 |
,Meropenem | 83 | 35 |
[back to top]
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure." (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Favorable | Unfavorable | Indeterminate |
---|
CAZ-AVI | 95 | 64 | 12 |
,Meropenem | 118 | 54 | 12 |
[back to top]
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 253 | 38 |
,Meropenem | 268 | 38 |
[back to top]
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 292 | 50 | 14 |
,Meropenem | 309 | 45 | 16 |
[back to top]
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 125 | 18 |
,Meropenem | 135 | 16 |
[back to top]
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 110 | 12 |
,Meropenem | 126 | 12 |
[back to top]
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. (NCT01808092)
Timeframe: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure | Indeterminate |
---|
CAZ-AVI | 143 | 23 | 5 |
,Meropenem | 161 | 18 | 5 |
[back to top]
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. (NCT01808092)
Timeframe: At the test-of-cure (TOC) visit (Day 21 to 25)
Intervention | participants (Number) |
---|
| Clinical cure | Clinical failure |
---|
CAZ-AVI | 199 | 58 |
,Meropenem | 211 | 59 |
[back to top]
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)
Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of seizures, diarrhea, renal disorder, and liver disorder relevant to the cephalosporin class within the ST and AEs with preferred term in the system organ class of nervous system disorder system organ class based on MedDRA 20.0) were reported in this outcome measure. (NCT02475733)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| AE in the ST of Diarrhea | AEoSI in the ST of Hypersensitivity/Anaphylaxis | AE in the ST of Liver Disorder | AE in the ST of Renal Disorder | AEs with PTs in the Nervous System Disorder SOC | AE of seizure |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 1.6 | 4.9 | 0 | 0 | 1.6 | 0 |
,Meropenem | 0 | 13.6 | 0 | 0 | 4.5 | 0 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. (NCT02475733)
Timeframe: Day 7
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 | 0 | 0 | 50.8 |
,Meropenem | 0 | 0 | 0 | 59.1 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit
CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: EOIV visit (anytime from Day 4 up to 16)
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 | 0 | 0 | 82.0 |
,Meropenem | 0 | 0 | 0 | 81.8 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit
CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 | 0 | 1.6 | 6.6 |
,Meropenem | 0 | 0 | 0 | 9.1 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit
CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02475733)
Timeframe: TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 | 0 | 3.3 | 42.6 |
,Meropenem | 0 | 0 | 0 | 59.1 |
[back to top]
Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms)
ECG parameters included maximum QT intervals using Fridericia's correction (QTcF). Maximum QTcF >450 millisecond (ms); maximum QTcF >480 ms; and maximum QTcF >500 ms. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline until the EOIV visit (anytime from Day 4 to 16)
Intervention | percentage of participants (Number) |
---|
| Maximum QTcF Interval : >450 ms | Maximum QTcF Interval : >480 ms | Maximum QTcF Interval : >500 ms |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 1.6 | 1.6 | 0 |
,Meropenem | 4.5 | 4.5 | 4.5 |
[back to top]
Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population
Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02475733)
Timeframe: TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 91.8 |
Meropenem | 95.5 |
[back to top]
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population
A participant was said to have clinical relapse if me either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 |
Meropenem | 0 |
[back to top]
Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population
Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| EOIV | EOT | TOC | LFU |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 96.0 | 90.0 | 90.0 | 90.0 |
,Meropenem | 100 | 100 | 94.7 | 94.7 |
[back to top]
Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population
Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02475733)
Timeframe: End of 72 hours study drug treatment on Day 1, EOIV (anytime from Day 4 up to 16), EOT visit (up to Day 17) and TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| End 72 hours study medication | EOIV | EOT | TOC |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 98.0 | 98.1 | 94.2 | 92.9 |
,Meropenem | 95.0 | 100 | 100 | 95.0 |
[back to top]
Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population
Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| EOIV | EOT | TOC | LFU |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 97.5 | 91.7 | 90.0 | 89.2 |
,Meropenem | 100 | 100 | 93.3 | 92.9 |
[back to top]
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. (NCT02475733)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| AEs | SAEs |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 52.5 | 8.2 |
,Meropenem | 59.1 | 4.5 |
[back to top]
Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population
Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). (NCT02475733)
Timeframe: EOT visit (up to Day 17)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 91.8 |
Meropenem | 100 |
[back to top]
Plasma Concentrations of Ceftazidime and Avibactam
(NCT02475733)
Timeframe: 15, 30-90, 300-360 minutes post-dose on Day 3
Intervention | nanogram per milliliter (Geometric Mean) |
---|
| Ceftazidime: 15 minute post-dose on Day 3 | Ceftazidime: 30-90 minute post-dose on Day 3 | Ceftazidime:300-360minute post-dose on Day 3 | Avibactam: 15 minute post-dose on Day 3 | Avibactam: 30-90 minute post-dose on Day 3 | Avibactam: 300-360 minute post-dose on Day 3 |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 63565.5 | 38048.0 | 4603.0 | 12186.2 | 6548.6 | 821.5 |
[back to top]
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Criteria for potentially clinically significant laboratory abnormalities: Chemistry (calcium: <0.7*lower limit of normal range [LLN] and >30 percent decrease from baseline [DFB]; alanine aminotransferase [ALT]: >3*upper limit of normal range [ULN] and >300 percent IFB; alanine aminotransferase [AST]: >3*ULN and >300 percent IFB) and hematology (platelets: >2*ULN and >100 percent IFB). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| Chemistry: Calcium | Chemistry: ALT | Chemistry: AST | Hematology: Platelets |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 1.9 | 1.7 | 1.8 | 3.3 |
,Meropenem | 0 | 0 | 0 | 0 |
[back to top]
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population
A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral). (NCT02475733)
Timeframe: LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 |
Meropenem | 0 |
[back to top]
Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population
Emergent Infections was an intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy, new infection was an intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment has finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). Participants with any (super infections or new infections) of the infections were reported. (NCT02475733)
Timeframe: TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 |
Meropenem | 0 |
[back to top]
Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population
Emergent infections were categorized as super infections and new infections. Superinfection: An intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: An intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Participants with any (super infections or new infections) of the infections were reported. (NCT02475733)
Timeframe: Baseline up to 50 days
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 0 |
Meropenem | 0 |
[back to top]
Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population
Favorable CR was defined as resolution of all acute signs and symptoms of complicated intra- abdominal infection (cIAIs), or improvement to such an extent that no further antimicrobial therapy was required, or improvement but not enough to switch to oral therapy and still on IV study drug at end of 72 hours and had met following criterion: absence of new signs and symptoms, improvement in at least 1 symptom/sign (fever, pain, tenderness, elevated White Blood Cells [WBCs], elevated c-reactive protein) from baseline and no worsening symptom/sign. (NCT02475733)
Timeframe: End of 72 hours study drug treatment on Day 1
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 93.4 |
Meropenem | 90.9 |
[back to top]
Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population
Favorable CR was resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: EOIV visit (anytime from Day 4 up to 16)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 96.7 |
Meropenem | 100 |
[back to top]
Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)
Intervention | degree Celsius (Mean) |
---|
| Baseline | Change at EOIV |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 37.35 | -0.78 |
,Meropenem | 37.16 | -0.60 |
[back to top]
Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)
Intervention | kilograms (Mean) |
---|
| Baseline | Change at EOIV |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 40.58 | -0.38 |
,Meropenem | 38.35 | -1.06 |
[back to top]
Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)
Intervention | beats per minute (Mean) |
---|
| Baseline | Change at EOIV |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 102.1 | -15.2 |
,Meropenem | 103.0 | -15.4 |
[back to top]
Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)
Intervention | breaths per minute (Mean) |
---|
| Baseline | Change at EOIV |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 22.4 | -1.3 |
,Meropenem | 22.9 | -1.3 |
[back to top]
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: Baseline, EOIV visit (anytime from Day 4 up to 16)
Intervention | millimeter of mercury (mmHg) (Mean) |
---|
| SBP: Baseline | SBP: Change at EOIV | DBP: Baseline | DBP: Change at EOIV |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 109.7 | -4.0 | 63.5 | 1.3 |
,Meropenem | 111.6 | -6.0 | 63.1 | -2.8 |
[back to top]
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit
Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02475733)
Timeframe: EOIV visit (anytime from Day 4 up to 16)
Intervention | percentage of participants (Number) |
---|
| Abdomen | Cardiovascular System | General Appearance | Head and Neck | Lymph Nodes | Musculoskeletal System | Neurological System | Respiratory System | Skin | Thyroid |
---|
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole | 6.6 | 0 | 1.6 | 0 | 0 | 0 | 0 | 3.3 | 1.6 | 0 |
,Meropenem | 18.2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Change From Baseline in Body Weight at End of Intravenous Treatment (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline, EOIV visit (anytime from Day 4 to 15)
Intervention | kilogram (Mean) |
---|
| Baseline | Change at EOIV |
---|
Cefepime | 25.24 | 0.14 |
,Ceftazidime- Avibactam (CAZ-AVI) | 24.55 | -0.08 |
[back to top]
Change From Baseline in Body Temperature at End of Intravenous Treatment (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline, EOIV visit (anytime from Day 4 to 15)
Intervention | degree Celsius (Mean) |
---|
| Baseline | Change at EOIV |
---|
Cefepime | 37.49 | -0.90 |
,Ceftazidime- Avibactam (CAZ-AVI) | 37.67 | -1.15 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR) at TOC: Clinically Evaluable (CE) Analysis Set at TOC
Favourable clinical response was defined as resolution of all acute signs/symptoms of cUTIs or improvement to such an extent that no further antimicrobial therapy was needed. Participants who met the following criterion: Incomplete resolution or worsening of cUTI signs or symptoms or development of new signs or symptoms requiring alternative non-study antimicrobial therapy or death in which cUTI was contributory. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02497781)
Timeframe: TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 93.9 |
Cefepime | 85.0 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR) at End of Treatment (EOT) Visit: Clinically Evaluable (CE) Analysis Set at EOT
Favourable clinical response was defined as a CR cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy). (NCT02497781)
Timeframe: EOT visit (up to Day 16)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 98.0 |
Cefepime | 94.7 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR) at End of Intravenous Treatment (EOIV) Visit: Clinically Evaluable (CE) Analysis Set at EOIV
Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had switched to oral therapy and had meet the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reactive-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: EOIV visit (anytime from Day 4 to 15)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 98.1 |
Cefepime | 95.5 |
[back to top]
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Analysis Set at LFU
A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral). (NCT02497781)
Timeframe: LFU visit (anytime up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 6.8 |
Cefepime | 0 |
[back to top]
Change From Baseline in Pulse Rate at End of Intravenous Treatment (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline, EOIV visit (anytime from Day 4 to 15)
Intervention | beats per minute (Mean) |
---|
| Baseline | Change at EOIV |
---|
Cefepime | 119.1 | -17.1 |
,Ceftazidime- Avibactam (CAZ-AVI) | 111.5 | -11.9 |
[back to top]
Plasma Concentrations of Ceftazidime and Avibactam
(NCT02497781)
Timeframe: 15, 30-90, 300-360 minutes post-dose on Day 3
Intervention | nanogram per milliliter (Geometric Mean) |
---|
| Ceftazidime: 15 minute post-dose on Day 3 | Ceftazidime: 30-90 minute post-dose on Day 3 | Ceftazidime:300-360minute post-dose on Day 3 | Avibactam: 15 minute post-dose on Day 3 | Avibactam: 30-90 minute post-dose on Day 3 | Avibactam: 300-360 minute post-dose on Day 3 |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 61411.2 | 47638.5 | 7285.7 | 9577.4 | 7046.4 | 936.3 |
[back to top]
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 36 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. (NCT02497781)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| AEs | SAEs |
---|
Cefepime | 53.6 | 7.1 |
,Ceftazidime- Avibactam (CAZ-AVI) | 53.7 | 11.9 |
[back to top]
Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Criteria for potentially clinically significant laboratory abnormalities: hematology (platelets: <0.4*lower limit of normal [LLN], >2*upper limit of normal [ULN], >40% decrease from baseline [DFB],>100% Increase from baseline [IFB]; Chemistry (Bicarbonate: <0.7*LLN, >1.3*ULN, >50% DFB, >30% IFB). (NCT02497781)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| Chemistry: Bicarbonate | Hematology: Platelets |
---|
Cefepime | 0 | 0 |
,Ceftazidime- Avibactam (CAZ-AVI) | 2.0 | 1.6 |
[back to top]
Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters
PCS criteria for abnormal value of ECG parameters: QT interval >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; Decrease from baseline (DFB) of >=30 msec; >=60 msec and >90 msec. QT interval using Bazett's correction (QTcB): >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. QT interval using Fridericia's correction (QTcF): >=450 msec; 480 msec; >=500 msec; IFB of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline until the EOIV visit (anytime from Day 4 to 15)
Intervention | percentage of participants (Number) |
---|
| QT Interval : >450 msec | QT Interval : >480 msec | QT Interval : >500 msec | Maximum IFB QT Interval : > 30 msec | Maximum IFB QT Interval : > 60 msec | Maximum IFB QT Interval : >90 msec | Maximum DFB QT Interval : > 30 msec | Maximum DFB QT Interval : > 60 msec | Maximum DFB QT Interval : > 90 msec | QTcB Interval : >450 msec | QTcB Interval : >480 msec | QTcB Interval : >500 msec | Maximum IFB QTcB Interval : > 30 msec | Maximum IFB QTcB Interval : > 60 msec | Maximum IFB QTcB Interval : > 90 msec | Maximum DFB QTcB Interval : > 30 msec | Maximum DFB QTcB Interval : > 60 msec | Maximum DFB QTcB Interval : > 90 msec | QTcF Interval : >450 msec | QTcF Interval : >480 msec | QTcF Interval : >500 msec | Maximum IFB QTcF Interval : > 30 msec | Maximum IFB QTcF Interval : > 60 msec | Maximum IFB QTcF Interval : > 90 msec | Maximum DFB QTcF Interval : > 30 msec | Maximum DFB QTcF Interval : > 60 msec | Maximum DFB QTcF Interval : > 90 msec |
---|
Cefepime | 0 | 0 | 0 | 14.3 | 3.6 | 0 | 17.9 | 0 | 0 | 3.6 | 0 | 0 | 14.3 | 3.6 | 0 | 7.1 | 3.6 | 3.6 | 0 | 0 | 0 | 14.3 | 3.6 | 0 | 10.7 | 3.6 | 0 |
,Ceftazidime- Avibactam (CAZ-AVI) | 0 | 0 | 0 | 19.4 | 7.5 | 3.0 | 9.0 | 4.5 | 1.5 | 16.4 | 11.9 | 7.5 | 17.9 | 7.5 | 3.0 | 10.4 | 6.0 | 1.5 | 6.0 | 6.0 | 6.0 | 17.9 | 3.0 | 3.0 | 9.0 | 3.0 | 1.5 |
[back to top]
Percentage of Participants With Favourable Microbiological Response: Microbiologically Evaluable (ME) Analysis Population
Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days). (NCT02497781)
Timeframe: EOIV visit (Day 4 to 15), EOT visit (up to Day 16)
Intervention | percentage of participants (Number) |
---|
| EOIV | EOT |
---|
Cefepime | 100 | 100 |
,Ceftazidime- Avibactam (CAZ-AVI) | 97.1 | 97.4 |
[back to top]
Percentage of Participants With Favourable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population
Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days). (NCT02497781)
Timeframe: EOIV visit (Day 4 to 15), EOT visit(up to Day 16)
Intervention | percentage of participants (Number) |
---|
| EOIV | EOT |
---|
Cefepime | 78.3 | 73.9 |
,Ceftazidime- Avibactam (CAZ-AVI) | 81.5 | 83.3 |
[back to top]
Percentage of Participants With Favourable Combined Response: Microbiological Intent-to-treat (Micro-ITT) Population
Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02497781)
Timeframe: EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| Favourable at EOIV | Favourable at TOC |
---|
Cefepime | 78.3 | 60.9 |
,Ceftazidime- Avibactam (CAZ-AVI) | 79.6 | 72.2 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR) at End of 72 Hours Treatment: Clinically Evaluable (CE) Analysis Set at 72 Hours
Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had improvement but not enough to switch to oral therapy and were still on IV study drug at End of 72 hours and had meet the following criterion: absence of new signs and symptoms, and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated CRP) from baseline, and with no worsening of any symptom or sign. (NCT02497781)
Timeframe: End of 72 hours study drug treatment on Day 1
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 100 |
Cefepime | 95.2 |
[back to top]
Percentage of Participants With Emergent Infections: Microbiologically Evaluable (ME) Analysis Population
Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported. (NCT02497781)
Timeframe: Baseline up to 50 days
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 7.3 |
Cefepime | 0 |
[back to top]
Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population
Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported. (NCT02497781)
Timeframe: Baseline up to 50 days
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 5.6 |
Cefepime | 0 |
[back to top]
Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Analysis Set at LFU
A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery, or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral). (NCT02497781)
Timeframe: LFU visit (anytime up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
Ceftazidime- Avibactam (CAZ-AVI) | 12.5 |
Cefepime | 0 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR): Microbiologically Evaluable (ME) Analysis Population
Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy). (NCT02497781)
Timeframe: EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| EOIV | EOT | TOC |
---|
Cefepime | 100 | 100 | 87.5 |
,Ceftazidime- Avibactam (CAZ-AVI) | 100 | 100 | 92.7 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR): Microbiological ITT (Micro-ITT) Analysis Population
Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy). (NCT02497781)
Timeframe: End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| End of 72 hours | EOIV | EOT | TOC |
---|
Cefepime | 95.7 | 95.7 | 95.7 | 82.6 |
,Ceftazidime- Avibactam (CAZ-AVI) | 90.7 | 96.3 | 90.7 | 88.9 |
[back to top]
Percentage of Participants With Favourable Clinical Response (CR): Intent-to-treat (ITT) Analysis Population
Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy). (NCT02497781)
Timeframe: End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| End of 72 hours | EOIV | EOT | TOC |
---|
Cefepime | 86.2 | 89.7 | 89.7 | 82.8 |
,Ceftazidime- Avibactam (CAZ-AVI) | 88.2 | 91.2 | 88.2 | 86.8 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02497781)
Timeframe: TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Cefepime | 0 | 0 | 41.7 | 58.3 |
,Ceftazidime- Avibactam (CAZ-AVI) | 0 | 0 | 25.0 | 75.0 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Treatment (EOIV) Visit
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: EOIV visit (anytime from Day 4 to 15)
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Cefepime | 0 | 0 | 13.6 | 86.4 |
,Ceftazidime- Avibactam (CAZ-AVI) | 0 | 0 | 20.0 | 80.0 |
[back to top]
Percentage of Participants With Creatinine Clearance (CrCl) at Day 7
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. (NCT02497781)
Timeframe: Day 7
Intervention | percentage of participants (Number) |
---|
| CrCl: <30mL/min/1.73 m^2 | CrCl: >=30 to <50mL/min/1.73 m^2 | CrCl: >=50 to <80mL/min/1.73 m^2 | CrCl: >=80mL/min/1.73 m^2 |
---|
Cefepime | 0 | 0 | 0 | 100 |
,Ceftazidime- Avibactam (CAZ-AVI) | 0 | 0 | 11.1 | 88.9 |
[back to top]
Percentage of Participants With Combined Response: Microbiologically Evaluable (ME) Analysis Population
Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). (NCT02497781)
Timeframe: EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| Favourable at EOIV | Favourable at TOC |
---|
Cefepime | 100 | 68.8 |
,Ceftazidime- Avibactam (CAZ-AVI) | 97.1 | 80.5 |
[back to top]
Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)
Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of diarrhea, renal disorder, hematological disorder and liver disorder relevant to the cephalosporin class within the safety topics (ST) based on MedDRA 20.0) were reported in this outcome measure. (NCT02497781)
Timeframe: Baseline until the LFU visit (up to a maximum study duration of 50 days)
Intervention | percentage of participants (Number) |
---|
| AE in the ST of Diarrhea | AE in the ST of Hematological Disorders | AEoSI in the ST of Hypersensitivity/Anaphylaxis | AE in the ST of Liver Disorder | AE in the ST of Renal Disorder |
---|
Cefepime | 10.7 | 0 | 7.1 | 0 | 0 |
,Ceftazidime- Avibactam (CAZ-AVI) | 7.5 | 0 | 7.5 | 1.5 | 0 |
[back to top]
Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Treatment (EOIV) Visit
Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: EOIV visit (anytime from Day 4 to 15)
Intervention | percentage of participants (Number) |
---|
| Abdomen | Cardiovascular System | General Appearance | Head and Neck | Lymph Nodes | Musculoskeletal System | Neurological System | Respiratory System | Skin | Thyroid |
---|
Cefepime | 3.6 | 0 | 0 | 3.6 | 3.6 | 0 | 0 | 0 | 7.1 | 0 |
,Ceftazidime- Avibactam (CAZ-AVI) | 0 | 1.5 | 0 | 1.5 | 0 | 0 | 0 | 3.0 | 3.0 | 0 |
[back to top]
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Treatment (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline, EOIV visit (anytime from Day 4 to 15)
Intervention | millimeter of mercury (mmHg) (Mean) |
---|
| SBP: Baseline | SBP: Change at EOIV | DBP: Baseline | DBP: Change at EOIV |
---|
Cefepime | 111.9 | -5.4 | 69.1 | -5.0 |
,Ceftazidime- Avibactam (CAZ-AVI) | 105.6 | -1.0 | 62.6 | 0.9 |
[back to top]
Change From Baseline in Respiratory Rate at End of Intravenous Treatment (EOIV) Visit
EOIV visit occurred within 24 hours after completion of last infusion of the study drug. (NCT02497781)
Timeframe: Baseline, EOIV visit (anytime from Day 4 to 15)
Intervention | breaths per minute (Mean) |
---|
| Baseline | Change at EOIV |
---|
Cefepime | 27.0 | -2.6 |
,Ceftazidime- Avibactam (CAZ-AVI) | 25.8 | -2.5 |
[back to top]
Peak Sputum Concentration
(NCT02504827)
Timeframe: 8 hours
Intervention | mg/L (Mean) |
---|
IV Ceftazidime/Avibactam | 2.5 |
[back to top]
Peak Plasma Concentration (Cmax)
(NCT02504827)
Timeframe: 8 hours
Intervention | mg/L (Mean) |
---|
IV Ceftazidime/Avibactam | 85.87 |
[back to top]
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients
(NCT02822950)
Timeframe: 2,4,6, 8 hours after receiving the drug
Intervention | Hours (Mean) |
---|
Ceftazadime/Avibactam | 4.3 |
[back to top]
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients
(NCT02822950)
Timeframe: 2,4,6, 8 hours after receiving the drug
Intervention | mg/liter (Mean) |
---|
Ceftazadime/Avibactam | 48 |
[back to top]
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients
(NCT02822950)
Timeframe: 2,4,6, 8 hours after receiving the drug
Intervention | Liters/hour (Mean) |
---|
Ceftazadime/Avibactam | 6.4 |
[back to top]
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients
(NCT02822950)
Timeframe: 2,4,6, 8 hours after receiving the drug
Intervention | mg*hour/liters (Mean) |
---|
Ceftazadime/Avibactam | 343 |
[back to top]
Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients
(NCT02822950)
Timeframe: 2,4,6, 8 hours after receiving the drug
Intervention | Liter (Mean) |
---|
Ceftazadime/Avibactam | 34 |
[back to top]
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Mean and standard deviation (SD) of the RCmax PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the Cmax on Day 7 by the Cmax on Day 1. Cmax (ug/mL) was estimated from plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 0.83 | 0.96 | 0.95 |
,AVYCAZ + ATM 2.0 | 0.91 | 1.01 | 0.97 |
[back to top]
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Mean and standard deviation (SD) of the AUC(0-Tau) (µg*hr/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis using linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. AVYCAZ CI and ATM CI were not reported. (NCT03978091)
Timeframe: Day 1
Intervention | µg*hr/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ IV | 35.80 | 223.00 |
[back to top]
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Mean and standard deviation (SD) of the AUC(0-Tau) (µg*hr/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis using linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. AVYCAZ CI and ATM CI were not reported. (NCT03978091)
Timeframe: Day 1
Intervention | µg*hr/mL (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 44.00 | 255.00 | 221.00 |
,AVYCAZ + ATM 2.0 | 42.40 | 241.00 | 295.00 |
[back to top]
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Mean and standard deviation (SD) of the AUC(0-inf) (µg*hr/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | µg*hr/mL (Mean) |
---|
| Aztreonam |
---|
ATM IV | 263.00 |
[back to top]
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Mean and standard deviation (SD) of the AUC(0-inf) (µg*hr/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | µg*hr/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 42.40 | 308.00 |
,AVYCAZ IV | 32.10 | 235.00 |
[back to top]
Area Under the Plasma Concentration-time Curve of Study Drug From Time of Dosing Extrapolated to Infinity [AUC(0-Inf)]
Mean and standard deviation (SD) of the AUC(0-inf) (µg*hr/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | µg*hr/mL (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 39.10 | 277.00 | 245.00 |
,AVYCAZ + ATM 2.0 | 36.10 | 249.00 | 317.00 |
[back to top]
Concentration of Study Drug at Steady State After Continuous Infusion (Css)
Mean and standard deviation (SD) of the Css (ug/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data for AVYCAZ CI and ATM CI. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 4.34 | 27.60 |
[back to top]
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Aztreonam |
---|
ATM CI | 93.80 |
,ATM IV | 89.10 |
[back to top]
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Mean and standard deviation (SD) of the Vss (L) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L (Mean) |
---|
| Aztreonam |
---|
ATM IV | 14.30 |
[back to top]
Incidence of Treatment-emergent Adverse Events, by System Organ Class (SOC) and Maximum Severity Level
Number of participants with an AE are summarized by MedDRA system organ class (SOC) and severity. Each participant is only counted once at the highest severity recorded. For clinical laboratory tests, mild abnormal laboratory values that were not, in the investigator's opinion, medically significant were not reported as adverse events. (NCT03978091)
Timeframe: Day 1 through Day 14
Intervention | Participants (Count of Participants) |
---|
| Cardiac Disorders72375878 | Cardiac Disorders72375879 | Cardiac Disorders72375880 | Cardiac Disorders72375881 | Cardiac Disorders72375882 | Cardiac Disorders72375883 | Eye disorders72375879 | Eye disorders72375880 | Eye disorders72375881 | Eye disorders72375882 | Eye disorders72375883 | Eye disorders72375878 | Gastrointestinal Disorders72375878 | Gastrointestinal Disorders72375879 | Gastrointestinal Disorders72375880 | Gastrointestinal Disorders72375881 | Gastrointestinal Disorders72375882 | Gastrointestinal Disorders72375883 | General disorders and administration site conditions72375878 | General disorders and administration site conditions72375879 | General disorders and administration site conditions72375880 | General disorders and administration site conditions72375881 | General disorders and administration site conditions72375882 | General disorders and administration site conditions72375883 | Infections and infestations72375878 | Infections and infestations72375879 | Infections and infestations72375880 | Infections and infestations72375881 | Infections and infestations72375882 | Infections and infestations72375883 | Injury, poisoning and procedural complications72375878 | Injury, poisoning and procedural complications72375879 | Injury, poisoning and procedural complications72375880 | Injury, poisoning and procedural complications72375881 | Injury, poisoning and procedural complications72375882 | Injury, poisoning and procedural complications72375883 | Investigations72375878 | Investigations72375879 | Investigations72375880 | Investigations72375881 | Investigations72375882 | Investigations72375883 | Musculoskeletal and connective tissue disorders72375878 | Musculoskeletal and connective tissue disorders72375879 | Musculoskeletal and connective tissue disorders72375880 | Musculoskeletal and connective tissue disorders72375881 | Musculoskeletal and connective tissue disorders72375882 | Musculoskeletal and connective tissue disorders72375883 | Nervous system disorders72375878 | Nervous system disorders72375879 | Nervous system disorders72375880 | Nervous system disorders72375881 | Nervous system disorders72375882 | Nervous system disorders72375883 | Renal and urinary disorders72375878 | Renal and urinary disorders72375879 | Renal and urinary disorders72375880 | Renal and urinary disorders72375881 | Renal and urinary disorders72375882 | Renal and urinary disorders72375883 | Respiratory, thoracic and mediastinal disorders72375878 | Respiratory, thoracic and mediastinal disorders72375879 | Respiratory, thoracic and mediastinal disorders72375880 | Respiratory, thoracic and mediastinal disorders72375881 | Respiratory, thoracic and mediastinal disorders72375882 | Respiratory, thoracic and mediastinal disorders72375883 | Skin and subcutaneous tissue disorders72375878 | Skin and subcutaneous tissue disorders72375879 | Skin and subcutaneous tissue disorders72375880 | Skin and subcutaneous tissue disorders72375881 | Skin and subcutaneous tissue disorders72375882 | Skin and subcutaneous tissue disorders72375883 | Vascular disorders72375878 | Vascular disorders72375879 | Vascular disorders72375880 | Vascular disorders72375881 | Vascular disorders72375882 | Vascular disorders72375883 |
---|
| Mild | Severe | None | Moderate |
---|
AVYCAZ IV | 2 |
AVYCAZ CI | 2 |
ATM IV | 4 |
ATM CI | 1 |
AVYCAZ + ATM 1.5 | 3 |
AVYCAZ + ATM 2.0 | 2 |
AVYCAZ IV | 1 |
AVYCAZ CI | 0 |
ATM IV | 0 |
ATM CI | 0 |
AVYCAZ + ATM 1.5 | 1 |
AVYCAZ + ATM 2.0 | 0 |
AVYCAZ + ATM 1.5 | 0 |
AVYCAZ IV | 5 |
AVYCAZ CI | 6 |
ATM CI | 6 |
AVYCAZ + ATM 1.5 | 4 |
AVYCAZ IV | 0 |
AVYCAZ IV | 8 |
AVYCAZ CI | 8 |
ATM IV | 8 |
ATM CI | 7 |
AVYCAZ + ATM 1.5 | 8 |
AVYCAZ + ATM 2.0 | 8 |
AVYCAZ IV | 3 |
AVYCAZ CI | 1 |
ATM IV | 2 |
AVYCAZ + ATM 1.5 | 5 |
AVYCAZ + ATM 2.0 | 3 |
AVYCAZ CI | 7 |
ATM IV | 6 |
ATM CI | 8 |
AVYCAZ + ATM 2.0 | 5 |
ATM IV | 3 |
ATM CI | 2 |
AVYCAZ + ATM 2.0 | 4 |
ATM IV | 1 |
AVYCAZ IV | 6 |
ATM IV | 7 |
AVYCAZ + ATM 1.5 | 7 |
AVYCAZ + ATM 2.0 | 1 |
AVYCAZ + ATM 2.0 | 7 |
AVYCAZ CI | 4 |
ATM CI | 3 |
AVYCAZ IV | 4 |
AVYCAZ CI | 3 |
AVYCAZ IV | 7 |
AVYCAZ + ATM 1.5 | 2 |
AVYCAZ + ATM 1.5 | 6 |
ATM IV | 5 |
AVYCAZ + ATM 2.0 | 6 |
[back to top]
Total Body Plasma Clearance of Study Drug (CL)
Mean and standard deviation (SD) of the CL (L/h) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L/h (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 12.90 | 7.26 | 6.18 |
,AVYCAZ + ATM 2.0 | 14.30 | 8.13 | 6.47 |
[back to top]
Total Body Plasma Clearance of Study Drug (CL)
Mean and standard deviation (SD) of the CL (L/h) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L/h (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 12.20 | 6.80 |
,AVYCAZ IV | 15.80 | 8.59 |
[back to top]
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Mean and standard deviation (SD) of the Vss (L) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 18.50 | 14.50 | 11.50 |
,AVYCAZ + ATM 2.0 | 24.30 | 19.20 | 13.80 |
[back to top]
Total Body Plasma Clearance of Study Drug (CL)
Mean and standard deviation (SD) of the CL (L/h) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L/h (Mean) |
---|
| Aztreonam |
---|
ATM IV | 7.74 |
[back to top]
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | h (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 1.99 | 1.86 | 1.99 |
,AVYCAZ + ATM 2.0 | 1.88 | 1.88 | 2.00 |
[back to top]
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Mean and standard deviation (SD) of the RAUC PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the AUC(0-8) (avibactam and ceftazidime) or AUC(0-6) (aztreonam) on Day 7 by the AUC(0-Tau) on Day 1. AUC(0-8) and AUC(0-6) (µg*hr/mL) on Day 7 and AUC(0-Tau) (µg*hr/mL) on Day 1 were estimated from plasma concentration-time data using Non-compartmental analysis with the linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Aztreonam |
---|
ATM IV | 0.90 |
[back to top]
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | h (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 2.85 | 2.25 |
,AVYCAZ IV | 1.82 | 2.14 |
[back to top]
Area Under the Plasma Concentration-time Curve Data of Study Drug During the Dosing Interval on Day 1 [AUC(0-Tau)]
Mean and standard deviation (SD) of the AUC(0-Tau) (µg*hr/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis using linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. AVYCAZ CI and ATM CI were not reported. (NCT03978091)
Timeframe: Day 1
Intervention | µg*hr/mL (Mean) |
---|
| Aztreonam |
---|
ATM IV | 266.00 |
[back to top]
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | h (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 1.81 | 1.93 | 1.99 |
,AVYCAZ + ATM 2.0 | 1.99 | 1.93 | 2.06 |
[back to top]
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | h (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 2.00 | 2.06 |
,AVYCAZ IV | 1.89 | 2.06 |
[back to top]
Time of Cmax (Maximum Plasma Concentration) of Study Drug After the First Dose (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | h (Mean) |
---|
| Aztreonam |
---|
ATM CI | 2.00 |
,ATM IV | 1.94 |
[back to top]
Renal Clearance of Study Drug (CLR)
Mean and standard deviation (SD) of the CLR (L/h) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma and urine concentration-time data using Non-compartmental analysis. Renal clearance was calculated as Ae(0-8)/AUC(0-8) for ceftazidime and avibactam and as AE(0-4)/AUC(0-4) for aztreonam where Ae(0-8) and Ae(0-4) are the amounts of study drug excreted into the urine from time of dosing to 8 or 4 h post-dose, respectively, and AUC(0-8) and AUC(0-4) are the areas under the plasma concentration-time curve from time of dosing to 8 or 4 h post-dose, respectively. (NCT03978091)
Timeframe: Day 1
Intervention | L/h (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 11.40 | 7.10 | 4.61 |
,AVYCAZ + ATM 2.0 | 14.70 | 9.42 | 4.50 |
[back to top]
Renal Clearance of Study Drug (CLR)
Mean and standard deviation (SD) of the CLR (L/h) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma and urine concentration-time data using Non-compartmental analysis. Renal clearance was calculated as Ae(0-8)/AUC(0-8) for ceftazidime and avibactam and as AE(0-4)/AUC(0-4) for aztreonam where Ae(0-8) and Ae(0-4) are the amounts of study drug excreted into the urine from time of dosing to 8 or 4 h post-dose, respectively, and AUC(0-8) and AUC(0-4) are the areas under the plasma concentration-time curve from time of dosing to 8 or 4 h post-dose, respectively. (NCT03978091)
Timeframe: Day 1
Intervention | L/h (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 11.70 | 6.92 |
,AVYCAZ IV | 11.10 | 5.70 |
[back to top]
Renal Clearance of Study Drug (CLR)
Mean and standard deviation (SD) of the CLR (L/h) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma and urine concentration-time data using Non-compartmental analysis. Renal clearance was calculated as Ae(0-8)/AUC(0-8) for ceftazidime and avibactam and as AE(0-4)/AUC(0-4) for aztreonam where Ae(0-8) and Ae(0-4) are the amounts of study drug excreted into the urine from time of dosing to 8 or 4 h post-dose, respectively, and AUC(0-8) and AUC(0-4) are the areas under the plasma concentration-time curve from time of dosing to 8 or 4 h post-dose, respectively. (NCT03978091)
Timeframe: Day 1
Intervention | L/h (Mean) |
---|
| Aztreonam |
---|
ATM CI | 3.90 |
,ATM IV | 4.25 |
[back to top]
Number of Participants With at Least One Grade 2 (Moderate) or Higher Treatment-emergent Adverse Event
Adverse events include local and systemic reactions. All Grade 2 (moderate) adverse events were reported, regardless of relationship to study product. Number of participants with an AE are summarized by MedDRA system organ class (SOC). Each participant is only counted once per SOC. (NCT03978091)
Timeframe: Day 1 through Day 11
Intervention | Participants (Count of Participants) |
---|
| Cardiac Disorders | Eye disorders | General disorders and administration site conditions | Infections and infestations | Injury, poisoning and procedural complications | Investigations | Nervous system disorders | Respiratory, thoracic and mediastinal disorders |
---|
ATM CI | 1 | 1 | 0 | 0 | 0 | 5 | 1 | 0 |
,ATM IV | 0 | 0 | 1 | 1 | 0 | 3 | 1 | 0 |
,AVYCAZ + ATM 1.5 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 1 |
,AVYCAZ + ATM 2.0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
,AVYCAZ CI | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,AVYCAZ IV | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 |
[back to top]
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Mean and standard deviation (SD) of the Cmin (ug/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 0.74 | 6.29 | 13.30 |
,AVYCAZ + ATM 2.0 | 0.72 | 6.28 | 18.90 |
[back to top]
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Mean and standard deviation (SD) of the Cmin (ug/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ IV | 0.52 | 5.52 |
[back to top]
Minimum Plasma Concentration of Study Drug Following Multiple Daily Dosing on Day 1 (Cmin)
Mean and standard deviation (SD) of the Cmin (ug/mL) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Aztreonam |
---|
ATM IV | 13.90 |
[back to top]
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 14.20 | 88.20 | 74.40 |
,AVYCAZ + ATM 2.0 | 12.80 | 69.80 | 90.30 |
[back to top]
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 4.58 | 31.80 |
,AVYCAZ IV | 10.70 | 63.60 |
[back to top]
Maximum Plasma Concentration of Study Drug Following Multiple Daily Dosing (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | ug/mL (Mean) |
---|
| Aztreonam |
---|
ATM IV | 78.40 |
[back to top]
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 15.80 | 82.70 | 71.20 |
,AVYCAZ + ATM 2.0 | 14.30 | 70.30 | 93.20 |
[back to top]
Maximum Plasma Concentration of Study Drug After the First Dose (Cmax)
Mean and standard deviation (SD) of the Cmax (ug/mL) PK parameter after the first dose were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 13.10 | 71.20 |
,AVYCAZ IV | 12.40 | 67.90 |
[back to top]
Time to Cmax (Maximum Plasma Concentration) of Study Drug Following Multiple Daily Dosing (Tmax)
Mean and standard deviation (SD) of the Tmax (h) PK parameter following multiple daily dosing were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | h (Mean) |
---|
| Aztreonam |
---|
ATM IV | 2.00 |
[back to top]
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Mean and standard deviation (SD) of the RAUC PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the AUC(0-8) (avibactam and ceftazidime) or AUC(0-6) (aztreonam) on Day 7 by the AUC(0-Tau) on Day 1. AUC(0-8) and AUC(0-6) (µg*hr/mL) on Day 7 and AUC(0-Tau) (µg*hr/mL) on Day 1 were estimated from plasma concentration-time data using Non-compartmental analysis with the linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ IV | 0.87 | 0.98 |
[back to top]
Volume of Distribution of Study Drug at Steady-state Based on the Last Observed Concentration (Vss)
Mean and standard deviation (SD) of the Vss (L) PK parameter were estimated from the Day 7 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data using Non-compartmental analysis. (NCT03978091)
Timeframe: Day 7
Intervention | L (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ CI | 17.40 | 12.60 |
,AVYCAZ IV | 25.90 | 19.90 |
[back to top]
Accumulation Ratio for AUC (Area Under the Plasma Concentration-time Curve of Study Drug) [RAUC]
Mean and standard deviation (SD) of the RAUC PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the AUC(0-8) (avibactam and ceftazidime) or AUC(0-6) (aztreonam) on Day 7 by the AUC(0-Tau) on Day 1. AUC(0-8) and AUC(0-6) (µg*hr/mL) on Day 7 and AUC(0-Tau) (µg*hr/mL) on Day 1 were estimated from plasma concentration-time data using Non-compartmental analysis with the linear trapezoidal linear interpolation method for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Avibactam | Ceftazidime | Aztreonam |
---|
AVYCAZ + ATM 1.5 | 0.80 | 0.95 | 0.91 |
,AVYCAZ + ATM 2.0 | 0.82 | 0.95 | 0.94 |
[back to top]
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Mean and standard deviation (SD) of the RCmax PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the Cmax on Day 7 by the Cmax on Day 1. Cmax (ug/mL) was estimated from plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Aztreonam |
---|
ATM IV | 0.88 |
[back to top]
Accumulation Ratio for Cmax (Maximum Plasma Concentration) (RCmax)
Mean and standard deviation (SD) of the RCmax PK parameter were estimated for ceftazidime, avibactam, and/or aztreonam by dividing the Cmax on Day 7 by the Cmax on Day 1. Cmax (ug/mL) was estimated from plasma concentration-time data using Non-compartmental analysis for AVYCAZ IV, ATM IV, AVYCAZ + ATM 1.5, and AVYCAZ + ATM 2.0. (NCT03978091)
Timeframe: Day 1 and Day 7
Intervention | Accumulation ratio (Mean) |
---|
| Avibactam | Ceftazidime |
---|
AVYCAZ IV | 0.88 | 0.96 |
[back to top]
Concentration of Study Drug at Steady State After Continuous Infusion (Css)
Mean and standard deviation (SD) of the Css (ug/mL) PK parameter were estimated from the Day 1 ceftazidime, avibactam, and/or aztreonam plasma concentration-time data for AVYCAZ CI and ATM CI. (NCT03978091)
Timeframe: Day 1
Intervention | ug/mL (Mean) |
---|
| Aztreonam |
---|
ATM CI | 58.80 |
[back to top]
Serum Levels of Ceftazidime and Avibactam Among Critically-ill Patients
PK samples obtained around standard of care dosing regimens immediately before and at 1, 2, 4, 6, and 8 hours after administration (NCT04358991)
Timeframe: 8 hours
Intervention | mcg/mL (Median) |
---|
| Ceftazidime Cmax | Avibactam Cmax |
---|
Subjects Included | 80.6 | 15.9 |
[back to top]
Time for Cmax (Tmax) of ATM
The Tmax was observed directly from data as time of first occurrence. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Hours (Median) |
---|
Cohort 1: Normal Renal Function | 2.92 |
Cohort 2: Severe Renal Impairment | 2.92 |
[back to top]
Tmax of AVI
The Tmax was observed directly from data as time of first occurrence. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Hours (Median) |
---|
Cohort 1: Normal Renal Function | 2.46 |
Cohort 2: Severe Renal Impairment | 2.92 |
[back to top]
Total Daily Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours at Steady-state (AUC0-24,ss) of Aztreonam (ATM)
AUC0-24,ss of ATM in Cohort 1 was calculated by 4*AUC0-tau (tau = 6 hours), where AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). AUC0-24,ss of ATM in Cohort 2 was calculated by 3*AUC0-tau (tau = 8 hours), where AUC0-tau was area under the plasma concentration-time profile from time 0 to time tau (the dosing interval). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Microgram*hour per milliliter (ug*hr/mL) (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 922.9 |
Cohort 2: Severe Renal Impairment | 733.5 |
[back to top]
Vss of AVI
Vss was calculated by CL*MRT, where CL was clearance and MRT was mean residence time. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | L (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 37.37 |
Cohort 2: Severe Renal Impairment | 27.78 |
[back to top]
Vz of AVI
The Vz was calculated by dose/(AUC0-tau*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve and AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). The dosing interval (tau) was 6 hours for the normal renal function group (Cohort 1) and 8 hours for the severe renal impairment group (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | L (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 55.83 |
Cohort 2: Severe Renal Impairment | 30.14 |
[back to top]
Ae0-tau of AVI
The Ae0-tau was the sum of (urine concentration*sample volume). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | mg (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 465.6 |
Cohort 2: Severe Renal Impairment | 270.0 |
[back to top]
Ae0-tau% of AVI
The Ae0-tau was calculated by 100*Ae0-tau/dose, where Ae0-tau was cumulative amount of drug recovered unchanged in urine up to time tau. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | Percent of dose (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 93.19 |
Cohort 2: Severe Renal Impairment | 119.9 |
[back to top]
Apparent Volume of Distribution (Vz) of ATM
The Vz was calculated by dose/(AUC0-tau*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve and AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). The dosing interval (tau) was 6 hours for the normal renal function group (Cohort 1) and 8 hours for the severe renal impairment group (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Liters (L) (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 24.25 |
Cohort 2: Severe Renal Impairment | 18.79 |
[back to top]
Apparent Volume of Distribution at Steady-state (Vss) of ATM
Vss was calculated by CL*MRT, where CL was clearance and MRT was mean residence time. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | L (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 23.70 |
Cohort 2: Severe Renal Impairment | 18.46 |
[back to top]
Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval)(AUC0-tau) of ATM
The AUC0-tau was calculated by linear/log trapezoidal method. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug*hr/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 230.8 |
Cohort 2: Severe Renal Impairment | 244.3 |
[back to top]
AUC0-24,ss of Avibactam (AVI)
AUC0-24,ss of AVI in Cohort 1 was calculated by 4*AUC0-tau (tau = 6 hours), where AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). AUC0-24,ss of AVI in Cohort 2 was calculated by 3*AUC0-tau (tau = 8 hours), where AUC0-tau was area under the plasma concentration-time profile from time 0 to time tau (the dosing interval). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug*hr/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 164.8 |
Cohort 2: Severe Renal Impairment | 204.6 |
[back to top]
AUC0-tau of AVI
The UC0-tau was calculated by linear/log trapezoidal method. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2).A (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug*hr/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 41.19 |
Cohort 2: Severe Renal Impairment | 68.31 |
[back to top]
CL of AVI
The CL was calculated by dose/AUC0-tau, where AUC0-tau was area under the plasma concentration-time profile from time 0 to to time tau (the dosing interval). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | L/hr (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 12.16 |
Cohort 2: Severe Renal Impairment | 3.295 |
[back to top]
Clearance (CL) of ATM
The CL was calculated by dose/AUC0-tau, where AUC0-tau was area under the concentration-time profile from time 0 to time tau (the dosing interval). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Liters per hour (L/hr) (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 6.499 |
Cohort 2: Severe Renal Impairment | 2.761 |
[back to top]
CLr of AVI
The CLr was calculated by Ae0-tau/AUC0-tau, where Ae0-tau was cumulative amount of drug recovered unchanged in urine up to time tau and AUC0-tau was area under the plasma concentration time profile from time 0 to time tau (the dosing interval). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | L/hr (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 11.30 |
Cohort 2: Severe Renal Impairment | 3.948 |
[back to top]
Cmax of AVI
The Cmax of AVI was observed directly from data. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 11.08 |
Cohort 2: Severe Renal Impairment | 11.35 |
[back to top]
Ctau of AVI
The Ctau was observed directly from data. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 3.100 |
Cohort 2: Severe Renal Impairment | 5.597 |
[back to top]
Cumulative Amount of Drug Recovered Unchanged in Urine up to Time Tau (Ae0-tau) of ATM
The Ae0-tau was the sum of (urine concentration*sample volume). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | Milligram (mg) (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 1047 |
Cohort 2: Severe Renal Impairment | 361.2 |
[back to top]
Maximum Plasma Concentration (Cmax) of ATM
The Cmax of ATM was observed directly from data. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Microgram per milliliter (ug/mL) (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 57.34 |
Cohort 2: Severe Renal Impairment | 43.34 |
[back to top]
Observed Plasma Concentration at the End of the Dosing Interval (Tau) (Ctau) of ATM
The Ctau was observed directly from data. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | ug/mL (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 21.43 |
Cohort 2: Severe Renal Impairment | 18.55 |
[back to top]
Percent of Dose Recovered Unchanged in Urine up to Time Tau (Ae0-tau%) of ATM
The Ae0-tau was calculated by 100*Ae0-tau/dose, where Ae0-tau was cumulative amount of drug recovered unchanged in urine up to time tau. The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | Percent of dose (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 69.68 |
Cohort 2: Severe Renal Impairment | 53.51 |
[back to top]
Renal Clearance (CLr) of ATM
The CLr was calculated by Ae0-tau/AUC0-tau, where Ae0-tau was cumulative amount of drug recovered unchanged in urine up to time tau and AUC0-tau was area under the plasma concentration time profile from time 0 to time tau (the dosing interval). The dosing interval (tau) was 6 hours for normal renal function (Cohort 1) and 8 hours for severe renal impairment (Cohort 2). (NCT04486625)
Timeframe: In Cohort 1, at predose on Day 3, during 0-2, 2-4, and 4-6 hours after the start of a maintenance dose infusion. In Cohort 2, at predose on Day 3, during 0-2, 2-4, 4-6, and 6-8 hours after the start of a maintenance dose infusion.
Intervention | L/hr (Geometric Mean) |
---|
Cohort 1: Normal Renal Function | 4.527 |
Cohort 2: Severe Renal Impairment | 1.477 |
[back to top]
t1/2 of AVI
The t1/2 was calculated by loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Hours (Mean) |
---|
Cohort 1: Normal Renal Function | 3.188 |
Cohort 2: Severe Renal Impairment | 6.524 |
[back to top]
Terminal Elimination Half-life (t1/2) of ATM
The t1/2 was calculated by loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. (NCT04486625)
Timeframe: Predose, 2, 3, 3.25, 3.5, 3.75, 4, 5, 6, 8, 12, 16, and 24 hours after start of a maintenance dose infusion on Day 3.
Intervention | Hours (Mean) |
---|
Cohort 1: Normal Renal Function | 2.605 |
Cohort 2: Severe Renal Impairment | 4.902 |
[back to top]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All-causality)
An adverse event (AE) is any untoward medical occurrence in a study participant administered a product; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: (1) results in death; (2) is life threatening (immediate risk of death); (3) requires inpatient hospitalization or prolongation of existing hospitalization; (4) results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) results in congenital anomaly/birth defect; or that is considered to be an important medical event. Treatment-emergent are events between first dose of study medication and up to at least 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A severe AE is defined as a event interferes significantly with participant's usual function. (NCT04486625)
Timeframe: Day 1 up to at least 28 days after last dose of study medication (maximum of 33 days).
Intervention | Participants (Count of Participants) |
---|
| Participants with AEs | Participants with serious AEs | Participants with severe AEs | Participants discontinued from study due to AEs | Participants discontinued study drug due to AEs and continue study | Participants with dose reduced or temporary discontinuation due to AEs |
---|
Cohort 1: Normal Renal Function | 2 | 0 | 0 | 0 | 0 | 0 |
,Cohort 2: Severe Renal Impairment | 3 | 0 | 0 | 0 | 0 | 0 |
[back to top]
[back to top]
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Following laboratory parameters were abnormal (without regard to baseline abnormality): hemoglobin, hematocrit, erythrocytes, lymphocytes, neutrophils, activated partial thromboplastin time, protein, urea nitrogen, creatinine, urate, urine glucose, and urine protein. (NCT04486625)
Timeframe: Days 1 to 3
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN) | Hematocrit (%) <0.8*LLN | Erythrocytes (10^6 per cubic millimeter [10^6/mm^3]) <0.8*LLN | Lymphocytes (10^3 per cubic millimeter [10^3/mm^3]) <0.8*LLN | Neutrophils (10^3/mm^3) >1.2*upper limit of normal (ULN) | Activated partial thromboplastin time (second) >1.1*ULN | Protein (g/dL) <0.8*LLN | Urea Nitrogen (milligram per deciliter [mg/dL]) >1.3*ULN | Creatinine (mg/dL) >1.3*ULN | Urate (mg/dL) >1.2*ULN | Urine glucose (mg/dL) >=1 | Urine protein (mg/dL) >=1 |
---|
Cohort 1: Normal Renal Function | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 2: Severe Renal Impairment | 3 | 3 | 4 | 1 | 1 | 1 | 1 | 5 | 5 | 3 | 3 | 1 |
[back to top]
Number of Participants With Categorical Post-Baseline Vital Signs Data
Categorical post-baseline vital signs included: (1) pulse rate: value less than (<) 40 beats per minute (bpm), lager than (>) 120 bpm; (2) supine diastolic blood pressure (DBP): value <50 mmHg, change of more than or equal to (>=) 20 mmHg increase, change of >=20 mmHg decrease; (3) supine systolic blood pressure (SBP): value <90 mmHg, change of >=30 mmHg increase, change of >=30 mmHg decrease. (NCT04486625)
Timeframe: Days 1 to 3
Intervention | Participants (Count of Participants) |
---|
| Pulse rate <40 bpm | Pulse rate >120 bpm | Supine DBP <50 mmHg | Supine DBP change >=20 mmHg increase | Supine DBP change >=20 mmHg decrease | Supine SBP <90 mmHg | Supine SBP change >=30 mmHg increase | Supine SBP change >=30 mmHg decrease |
---|
Cohort 1: Normal Renal Function | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 2: Severe Renal Impairment | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
[back to top]
Number of Participants With Abnormal Electrocardiogram (ECG)
Criteria for ECG abnormalities: maximum QT interval >500 milliseconds (msec); maximum QTc interval of >=450 msec to less than or equal to (<=) 480 msec, >480 msec, and >500 msec and a maximum change of <30 change<=60 or >60 msec from baseline; maximum QTcF (Fridericia's Correction) interval of >=450 msec to <=480 msec, >480 msec, and >500 msec and a maximum change of <30 change<=60 or >60 msec from baseline. (NCT04486625)
Timeframe: Days 1 to 3
Intervention | Participants (Count of Participants) |
---|
| QT interval value > 500 msec | 450 msec<= QTc interval value <=480 msec | QTc interval value >480 msec | QTc interval value >500 msec | 30 msec< QTc interval change <=60 msec | QTc interval change >60 msec | 450 msec<= QTcF interval value <=480 msec | QTcF interval value >480 msec | QTcF interval value >500 msec | 30 msec< QTcF interval change <=60 msec | QTcF interval change >60 msec |
---|
Cohort 1: Normal Renal Function | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cohort 2: Severe Renal Impairment | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
[back to top]
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam
Tmax was defined as time to reach maximum observed plasma concentration. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | hours (Median) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 2.92 | 2.92 |
[back to top]
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam
Rac was obtained from AUCtau at steady state (Day 4) divided by AUCtau after single dose (Day 1). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ratio (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1.204 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1
Intervention | nanograms/millilitre/hour (ng*hr/mL) (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 236.7 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 44.41 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 285.2 |
[back to top]
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 177.7 |
[back to top]
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1142 |
[back to top]
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam
Rac was obtained from AUCtau at steady state (Day 4) divided by AUCtau after single dose (Day 1). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ratio (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1.049 |
[back to top]
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss was the Vz at steady-state. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | Liter (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 21.36 | 17.96 |
[back to top]
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam
Apparent volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss was the Vz at steady-state. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | Liter (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 13.69 | 12.81 |
[back to top]
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | Liter (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 30.14 | 65.41 |
[back to top]
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | Liter (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 14.09 | 14.22 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 47.33 | 49.47 |
[back to top]
Number of Participants With Abnormal Vital Signs
Criteria for vital signs abnormalities: increase or decrease from baseline in supine Systolic Blood Pressure (SBP) >=30 mm Hg and increase or decrease from baseline in supine Diastolic Blood Pressure (DBP) >=20 mm Hg. (NCT04973826)
Timeframe: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Intervention | Participants (Count of Participants) |
---|
| Supine Diastolic Blood Pressure (mmHg): Change >= 20 mmHg increase from baseline | Supine Systolic Blood Pressure (mmHg): Change >= 30 mmHg increase from baseline | Supine Diastolic Blood Pressure (mmHg): Change >= 20 mmHg decrease from baseline | Supine Systolic Blood Pressure (mmHg): Change >= 30 mmHg decrease from baseline |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 0 | 0 | 0 | 0 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 289.6 | 337.5 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 47.29 | 49.59 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 289.2 | 337.6 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 47.23 | 49.47 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug*hr/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 287.8 | 336.4 |
[back to top]
Clearance (CL) on Day 1 & 4 of Avibactam
CL was a quantitative measure of the rate at which a drug substance was removed from the body. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | litre per hour (L/hr) (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 10.56 | 11.26 |
[back to top]
Clearance (CL) on Day 1 & 4 of Aztreonam
CL was a quantitative measure of the rate at which a drug substance was removed from the body. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | litre per hour (L/hr) (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 5.188 | 5.261 |
[back to top]
Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | ug/mL (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 13.93 | 14.03 |
[back to top]
Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | micrograms per milliliter (ug/mL) (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 69.44 | 79.66 |
[back to top]
Number of Participants With Abnormal Electrocardiograms (ECGs)
"ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.~2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.~3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline." (NCT04973826)
Timeframe: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Intervention | Participants (Count of Participants) |
---|
| PR INTERVAL NOT OTHERWISE SPECIFIED (msec): %Change >= 25/50% | QRS INTERVAL NOT OTHERWISE SPECIFIED (msec): %Change >= 50% | QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (msec): 30 < Change <= 60 | QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (msec): Change > 60 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 0 | 0 | 0 | 0 |
[back to top]
Number of Participants With Abnormal Laboratory Assessments
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (basophils); clinical chemistry (urate); urinalysis (urine hemoglobin, nitrite, urine erythrocytes). (NCT04973826)
Timeframe: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Intervention | Participants (Count of Participants) |
---|
| HEMATOLOGY: Basophils (10^3/mm^3) > 1.2x upper limit of normal (ULN) | CLINICAL CHEMISTRY: Urate (mg/dL) > 1.2x ULN | URINALYSIS: URINE Hemoglobin >= 1 | URINALYSIS: URINE Erythrocytes >= 20 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1 | 1 | 3 | 2 |
[back to top]
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1
Intervention | ng*hr/mL (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 42.36 |
[back to top]
Number of Participants With an Adverse Event (AE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. (NCT04973826)
Timeframe: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Intervention | Participants (Count of Participants) |
---|
| Participants with treatment-emergent adverse events (all-causality) | Participants with treatment-emergent adverse events (treatment-related) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 2 | 1 |
[back to top]
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam
Accumulation ratio based on maximum plasma concentration (Rac,cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 4) divided by Cmax at first dose (Day 1). The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ratio (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1.149 |
[back to top]
Renal Clearance (CLr) on Day 1 & 4 of Avibactam
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | litre per hour (L/hr) (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 12.09 | 12.65 |
[back to top]
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam
Accumulation ratio based on maximum plasma concentration (Rac,cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 4) divided by Cmax at first dose (Day 1). The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 4
Intervention | ratio (Geometric Mean) |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1.006 |
[back to top]
Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | hours (Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 2.003 | 4.061 |
[back to top]
Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | hours (Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 1.890 | 1.886 |
[back to top]
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam
Tmax was defined as time to reach maximum observed plasma concentration. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | hours (Median) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 2.44 | 2.46 |
[back to top]
Renal Clearance (CLr) on Day 1 & 4 of Aztreonam
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage. (NCT04973826)
Timeframe: Post dose on day 1 and day 4
Intervention | litre per hour (L/hr) (Geometric Mean) |
---|
| Day 1 | Day 4 |
---|
AZTREONAM-AVIBACTAM (ATM-AVI) | 4.277 | 4.487 |
[back to top]