aztreonam and Adverse Drug Event

aztreonam has been researched along with Adverse Drug Event in 4 studies

Aztreonam: A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.
aztreonam : A synthetic monocyclic beta-lactam antibiotic (monobactam), used primarily to treat infections caused by Gram-negative bacteria. It inhibits mucopeptide synthesis in the bacterial cell wall, thereby blocking peptidoglycan crosslinking.

Research

Studies (4)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)

"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)." (NCT01811732)
Timeframe: Study Day 14 +/- 1 day

Objective Response at 48 to 72 Hours (FDA Primary Endpoint)

A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug. (NCT01811732)
Timeframe: 48 to 72 hours after starting treatment

Clinical Response at TOC

Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose. (NCT02202135)
Timeframe: 7 to 20 days after last dose of study drug

Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC

The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC. (NCT01499277)
Timeframe: 21 to 42 days after the last dose of study drug

Clinical Response at End of Treatment (EOT) in MITT Analysis Set

The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. (NCT01499277)
Timeframe: On day of last dose of study drug (or + 1 day)

Clinical Response at EOT in CE Analysis Set

The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. (NCT01499277)
Timeframe: On day of last dose of study drug (or +1 day)

Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set

The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug

Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set

The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug

Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set

The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline. (NCT01499277)
Timeframe: 48 to 72 hours after first dose of study drug

Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set

Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug

Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME

Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug

Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set

Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug

Reviews

1 review available for aztreonam and Adverse Drug Event

Trials

2 trials available for aztreonam and Adverse Drug Event

Other Studies

1 other study available for aztreonam and Adverse Drug Event