Compounds > ceftobiprole medocaril
Page last updated: 2024-10-15

ceftobiprole medocaril

Description

ceftobiprole medocaril: a ceftobiprole prodrug [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID135413543
SCHEMBL ID4401305
MeSH IDM0491785

Synonyms (27)

Synonym
ro-65-5788
ro-65-5788/001
bal-5788
ceftobiprole medocaril
D08886
ceftobiprole medocaril (usan)
252188-71-9
bal5788
ro 65-5788
ceftobiprole medocaril sodium
bal5788-001
ceftobiprole medocaril [usan:inn]
unii-n99027v28j
5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2z)-(5-amino-1,2,4-thiadiazol-3-yl) (hydroxyimino)acetyl)amino)-3-((e)-((3'r)-1'-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-2-oxo(1,3'-bipyrrolidin)-3-ylidene)methyl)-8-oxo-, monosodium
(6r,7r)-7-(((2z)-(5-amino-1,2,4-thiadiazol-3-yl)(hydroxyimino)-acetyl)amino)-3-((e)-((3'r)-1'-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-2-oxo(1,3'-bipyrrolidin)-3-ylidene)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monoso
n99027v28j ,
ceftobiprole medocaril [ema epar]
ceftobiprole medocaril [usan]
ceftobiprole medocaril sodium salt [mi]
ceftobiprole medocaril [mart.]
ceftobiprole medocaril sodium [who-dd]
SCHEMBL4401305
HY-106574A
ceftobiprole medocaril (sodium)
sodium;(6r,7r)-7-[[(2z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-hydroxyiminoacetyl]amino]-3-[(e)-[1-[(3r)-1-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methoxycarbonyl]pyrrolidin-3-yl]-2-oxopyrrolidin-3-ylidene]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy
DTXSID601021562
CS-0103172

Research Excerpts

Overview

Ceftobiprole medocaril is a broad-spectrum 5th-generation cephalosporin. It has activity against Gram-positives such as methicillin-resistant Staphylococcus aureus. It also works against gram-negatives such as Pseudomonas aeruginosa.

ExcerptReference
"Ceftobiprole medocaril is a broad-spectrum 5th-generation cephalosporin with activity against Gram-positives such as methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae, and against Gram-negatives such as Pseudomonas aeruginosa. "( Ceftobiprole medocaril.
González-Jiménez, P; Latorre, A; Méndez, R, 2022)
"Ceftobiprole medocaril is a fifth-generation cephalosporin approved in Europe as single-agent therapy for hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). "( Ceftobiprole medocaril in the treatment of hospital-acquired pneumonia.
Scheeren, TW, 2015)
"Ceftobiprole medocaril is an extended-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus spp., vancomycin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, vancomycin-resistant Enterococcus faecalis, Enterobacteriaceae, and Pseudomonas aeruginosa. "( Ceftobiprole: an extended-spectrum anti-methicillin-resistant Staphylococcus aureus cephalosporin.
Anderson, SD; Gums, JG, 2008)

Effects

Ceftobiprole medocaril has been evaluated in two phase III clinical trials for the treatment of complicated skin infections. The drug is designed specifically to bind to this penicillin-resistant target.

ExcerptReference
"Ceftobiprole medocaril has a broad spectrum of activity against Gram-positive bacteria (including methicillin-resistant staphylococci, penicillin-resistant pneumococci and Enterococcus faecalis) and Gram-negative bacteria."( Ceftobiprole Medocaril: BAL5788, JNJ 30982081, JNJ30982081, RO 65-5788, RO 655788.
, 2006)
"Ceftobiprole medocaril has been evaluated in two phase III clinical trials for the treatment of complicated skin infections and skin structure infections."( Ceftobiprole medocaril: a new generation beta-lactam.
Del Pozo, JL; Patel, R, 2008)
"Ceftobiprole medocaril has been designed specifically to bind to this penicillin-resistant target."( Ceftobiprole Medocaril: BAL5788, JNJ 30982081, JNJ30982081, RO 65-5788, RO 655788.
, 2006)

Pharmacokinetics

ExcerptReference
" Ceftobiprole is rapidly eliminated, primarily unchanged, by renal excretion, with a terminal elimination half-life of 3 hours; the predominant mechanism responsible for elimination is glomerular filtration, with approximately 89% of the dose being excreted as the prodrug, active drug (ceftobiprole) and open-ring metabolite."( Pharmacokinetics and pharmacodynamics of ceftobiprole, an anti-MRSA cephalosporin with broad-spectrum activity.
Murthy, B; Schmitt-Hoffmann, A, 2008)
" This review summarizes the pharmacokinetic profile of ceftobiprole, and considers the pharmacokinetic parameters and pharmacodynamics underlying the choice of dosing regimen."( Pharmacokinetics and Dosing of Ceftobiprole Medocaril for the Treatment of Hospital- and Community-Acquired Pneumonia in Different Patient Populations.
Mouton, JW; Pea, F; Torres, A, 2016)
"Ceftobiprole shows many similar pharmacokinetic properties to other cephalosporins, except for not being orally bioactive, and that it is administered by IV infusion as the prodrug ceftobiprole medocaril, which is subsequently hydrolyzed in the blood into the active molecule."( Ceftobiprole: pharmacokinetics and PK/PD profile.
Azanza Perea, JR; Sádaba Díaz de Rada, B, 2019)

Dosage Studied

ExcerptReference
" High-dose regimens of ceftobiprole medocaril (equivalent to 150 mg/kg of ceftobiprole) or 50 mg/kg vancomycin produced nearly identical average peak and trough levels of ceftobiprole and vancomycin in tissue cage fluid, which exceeded the MBC of either antibiotic towards strain MRGR3 for > or =75% of each dosing interval."( Intensive therapy with ceftobiprole medocaril of experimental foreign-body infection by methicillin-resistant Staphylococcus aureus.
Bento, M; Gjinovci, A; Lew, DP; Li, D; Schrenzel, J; Vaudaux, P, 2005)
" However, the pharmacodynamics of ceftobiprole are similar in males and females, and dosing adjustments are not required based on gender."( Pharmacokinetics and pharmacodynamics of ceftobiprole, an anti-MRSA cephalosporin with broad-spectrum activity.
Murthy, B; Schmitt-Hoffmann, A, 2008)
" Two clinical trials support these dosing regimens for cSSSIs."( Ceftobiprole: an extended-spectrum anti-methicillin-resistant Staphylococcus aureus cephalosporin.
Anderson, SD; Gums, JG, 2008)
" Ceftobiprole is available only for intravenous administration; recommended dosage regimens have not been approved by the FDA as of this writing."( Ceftobiprole: first cephalosporin with activity against methicillin-resistant Staphylococcus aureus.
Rybak, MJ; Vidaillac, C, 2009)
" The article also provides discussion of how PK/PD parameters play a role in the outcome of HAP treatment and how dosing in ventilator-associated pneumonia (VAP) should be reconsidered in light of altered PK/PD."( Pharmacokinetic and pharmacodynamics evaluation of ceftobiprole medocaril for the treatment of hospital-acquired pneumonia.
Lagacé-Wiens, PR; Rubinstein, E, 2013)
" This review summarizes the pharmacokinetic profile of ceftobiprole, and considers the pharmacokinetic parameters and pharmacodynamics underlying the choice of dosing regimen."( Pharmacokinetics and Dosing of Ceftobiprole Medocaril for the Treatment of Hospital- and Community-Acquired Pneumonia in Different Patient Populations.
Mouton, JW; Pea, F; Torres, A, 2016)
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (28)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's11 (39.29)29.6817
2010's15 (53.57)24.3611
2020's2 (7.14)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials4 (14.29%)5.53%
Reviews15 (53.57%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other9 (32.14%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (25)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia[NCT00229008]Phase 3106 participants (Actual)Interventional2005-11-30Completed
A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Pediatric [NCT03439124]Phase 3138 participants (Actual)Interventional2017-11-27Completed
A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections[NCT03137173]Phase 3679 participants (Actual)Interventional2018-02-19Completed
A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia[NCT00326287]Phase 3638 participants (Actual)Interventional2006-06-30Completed
Retrospective Chart Review to Evaluate the Safety Profile of Ceftobiprole in Patients With Impaired Hepatic or Renal Function or Immunosuppression[NCT04170309]428 participants (Actual)Observational2020-03-30Completed
Effect of Ceftobiprole on the Intestinal Human Microflora Following Multiple-dose Administration in Healthy Female and Male Subjects[NCT00965042]Phase 112 participants (Actual)Interventional2009-04-30Completed
Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia[NCT00771719]Phase 11 participants (Actual)Interventional2008-10-31Terminated(stopped due to Study closed due to lack of enrollment; challenging patient population.)
An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics[NCT02527681]Phase 115 participants (Actual)Interventional2016-11-22Terminated(stopped due to on July 07, 2020 due to slow enrollment; there were no safety concerns.)
A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia[NCT04171674]12 participants (Anticipated)Interventional2021-09-30Not yet recruiting
An Open-Label Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis[NCT01030731]Phase 112 participants (Actual)Interventional2007-05-31Completed
Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients[NCT01026558]Phase 125 participants (Actual)Interventional2007-08-31Completed
An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients =3 Months to 17<18 Years of Age, Undergoing Treatment With Systemic Antibiotics[NCT01026636]Phase 164 participants (Actual)Interventional2007-08-31Completed
Prospective Study Evaluating Plasma Exposure of Optimized Antibiotic Therapy According to TDM in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)[NCT04132115]104 participants (Anticipated)Observational2019-10-01Recruiting
Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units[NCT00770978]Phase 133 participants (Actual)Interventional2008-11-30Completed
Open-Label, Pharmacokinetic Study of the Penetration of Ceftobiprole Into Bone[NCT00771524]Phase 122 participants (Actual)Interventional2009-04-30Completed
An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers[NCT01026740]Phase 115 participants (Actual)Interventional2007-06-30Completed
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections[NCT00210899]Phase 3828 participants (Actual)Interventional2005-09-30Completed
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections[NCT00228982]Phase 3784 participants (Actual)Interventional2004-10-31Completed
Randomized, Open-Label Study Evaluating the Safety and Rate of Bacterial Clearance of Ceftobiprole 500 Milligram Every 8 Hours Compared to Conventional Therapy in the Treatment of Hospitalized Subjects With Staphylococcus Aureus Bacteremia[NCT00505258]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to The study was withdrawn due to lack of an appropriate patient population.)
A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia[NCT00210964]Phase 3781 participants (Actual)Interventional2005-04-30Completed
Multicenter, Randomized, Double-Blind Study of Ceftobiprole Versus Comparators in the Treatment of Patients With Fever and Neutropenia[NCT00529282]Phase 32 participants (Actual)Interventional2007-10-31Terminated(stopped due to Study discontinued due to administrative reasons unrelated to safety)
Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device[NCT03317093]Phase 25 participants (Actual)Interventional2018-03-29Completed
Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center[NCT04409769]22 participants (Actual)Observational2020-02-01Completed
A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis[NCT05856227]Phase 315 participants (Anticipated)Interventional2023-08-06Recruiting
A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis[NCT03138733]Phase 3390 participants (Actual)Interventional2018-08-26Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT02527681 (4) [back to overview]AUC0-last
NCT02527681 (4) [back to overview]Cmax
NCT02527681 (4) [back to overview]T>MIC of 4 mg/L
NCT02527681 (4) [back to overview]Tmax
NCT03137173 (3) [back to overview]Early Clinical Response
NCT03137173 (3) [back to overview]Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population
NCT03137173 (3) [back to overview]Investigator-assessed Clinical Success in the ITT Population
NCT03138733 (6) [back to overview]Number of Patients With Microbiological Eradication at the PTE Visit
NCT03138733 (6) [back to overview]Time to Staphylococcus Aureus Bloodstream Clearance
NCT03138733 (6) [back to overview]All-cause Mortality at the PTE Visit
NCT03138733 (6) [back to overview]Number of Patients With or Without Adverse Events (AEs)
NCT03138733 (6) [back to overview]Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit
NCT03138733 (6) [back to overview]Number of Patients With or Without Overall Success at the PTE Visit in the CE Population
NCT03439124 (5) [back to overview]Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population
NCT03439124 (5) [back to overview]Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT)
NCT03439124 (5) [back to overview]Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population
NCT03439124 (5) [back to overview]Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population
NCT03439124 (5) [back to overview]Adverse Events

AUC0-last

The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last) (NCT02527681)
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

Interventionμg•hours/mL (Median)
Ceftobiprole PK Population60.6

[back to top]

Cmax

The maximum observed plasma concentration (Cmax) (NCT02527681)
Timeframe: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

Interventionμg/mL (Median)
Ceftobiprole PK Population11.2

[back to top]

T>MIC of 4 mg/L

The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T>MIC of 4 mg/L) (NCT02527681)
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

Interventionhours (Median)
Ceftobiprole PK Population5.40

[back to top]

Tmax

The time of maximum observed plasma concentration (Tmax) (NCT02527681)
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

Interventionhours (Median)
Ceftobiprole PK Population4.00

[back to top]

Early Clinical Response

Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population (NCT03137173)
Timeframe: 48-72 hours after start of study drug treatment

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril306
Vancomycin+Aztreonam303

[back to top]

Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population

Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the clinically evaluable (CE) population (NCT03137173)
Timeframe: 15-22 days after randomization

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril277
Vancomycin+Aztreonam279

[back to top]

Investigator-assessed Clinical Success in the ITT Population

Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the ITT population (NCT03137173)
Timeframe: 15-22 days after randomization

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril302
Vancomycin+Aztreonam306

[back to top]

Number of Patients With Microbiological Eradication at the PTE Visit

Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE. (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

InterventionParticipants (Count of Participants)
Ceftobiprole155
Daptomycin153

[back to top]

Time to Staphylococcus Aureus Bloodstream Clearance

Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection (NCT03138733)
Timeframe: Up to 6 weeks post-randomization

InterventionDays (Median)
Ceftobiprole4
Daptomycin4

[back to top]

All-cause Mortality at the PTE Visit

Comparison of all-cause mortality rates in the mITT population (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Patients diedPatients alive
Ceftobiprole17172
Daptomycin18180

[back to top]

Number of Patients With or Without Adverse Events (AEs)

Treatment-emergent adverse events in the safety population (NCT03138733)
Timeframe: AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)

,
InterventionParticipants (Count of Participants)
Any adverse events (AEs)Any drug-related AEAny severe AEsAny study drug-related severe AEsAny serious adverse events (SAE)Any drug-related SAEsAny AE leading to treatment discontinuationStudy drug-related AEs leading to treatment discontinuationAny AE leading to deathStudy drug-related AEs leading to deathAny AE of special interest (AESI)Any drug-related AESI
Ceftobiprole1212529136218917095
Daptomycin1171138245418318074

[back to top]

Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit

"Comparison of overall success rates in the mITT population~Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder):~Patient alive at Day 70 (± 5 days) post-randomization.~No new metastatic foci or complications of the SAB infection.~Resolution or improvement of SAB-related clinical signs and symptoms.~Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)" (NCT03138733)
Timeframe: PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Number of respondersNumber of non-responders
Ceftobiprole13257
Daptomycin13662

[back to top]

Number of Patients With or Without Overall Success at the PTE Visit in the CE Population

"Comparison of overall success rates in the Clinical Evaluable (CE) population~Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder):~Patient alive at Day 70 (± 5 days) post-randomization.~No new metastatic foci or complications of the SAB infection.~Resolution or improvement of SAB-related clinical signs and symptoms.~Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)" (NCT03138733)
Timeframe: At PTE visit on Day 70 (± 5 days) post-randomization

,
InterventionParticipants (Count of Participants)
Number of respondersNumber of non-responders
Ceftobiprole12736
Daptomycin13037

[back to top]

Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population

Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the CE population between ceftobiprole and the comparator at the TOC visit. (NCT03439124)
Timeframe: At the TOC visit

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril80
IV Standard-of-care Cephalosporin41

[back to top]

Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT)

Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the ITT population between ceftobiprole and the comparator at the TOC visit. (NCT03439124)
Timeframe: At the test-of-cure (TOC) visit

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril85
IV Standard-of-care Cephalosporin43

[back to top]

Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population

Comparison of early clinical response rates in the CE population between ceftobiprole and the comparator at Day 4. (NCT03439124)
Timeframe: At Day 4

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril84
IV Standard-of-care Cephalosporin39

[back to top]

Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population

Comparison of early clinical response rates in the ITT population between ceftobiprole and the comparator at Day 4. (NCT03439124)
Timeframe: At Day 4

InterventionParticipants (Count of Participants)
Ceftobiprole Medocaril90
IV Standard-of-care Cephalosporin41

[back to top]

Adverse Events

Reported are adverse events (AEs) during the first 3 days of IV therapy and while patients were on IV therapy irrespective of when they switched to oral antibiotic treatment. (NCT03439124)
Timeframe: Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days

InterventionParticipants (Count of Participants)
First 3 days of IV therapy72366975First 3 days of IV therapy72366974While on IV therapy72366974While on IV therapy72366975
No TEAENon-Serious TEAESerious TEAETEAE leading to death
Ceftobiprole Medocaril10
IV Standard-of-care Cephalosporin5
Ceftobiprole Medocaril1
Ceftobiprole Medocaril83
IV Standard-of-care Cephalosporin39
Ceftobiprole Medocaril17
IV Standard-of-care Cephalosporin8
Ceftobiprole Medocaril2
Ceftobiprole Medocaril0
IV Standard-of-care Cephalosporin0
Ceftobiprole Medocaril75
IV Standard-of-care Cephalosporin36

[back to top]
SubstanceRelationship StrengthStudiesTrialsClassesRoles
vancomycin
Vancomycin: Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to RISTOCETIN that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear.. vancomycin : A complex glycopeptide from Streptomyces orientalis. It inhibits a specific step in the synthesis of the peptidoglycan layer in the Gram-positive bacteria Staphylococcus aureus and Clostridium difficile.		10.8242glycopeptideantibacterial drug;
antimicrobial agent;
bacterial metabolite
cephalosporin c
cephalosporin C: RN given refers to parent cpd; structure in Merck, 9th ed, #1937. cephalosporin C : A cephalosporin antibiotic carrying a 3-acetoxymethyl substituent and a 6-oxo-N(6)-L-lysino group at position 7.		12.94295cephalosporinfungal metabolite
oxazolidin-2-one
Oxazolidinones: Derivatives of oxazolidin-2-one. They represent an important class of synthetic antibiotic agents.. oxazolidin-2-one : An oxazolidinone that is 1,3-oxazolidine with an oxo substituent at position 2.. oxazolidinone : An oxazolidine containing one or more oxo groups.		6.7933carbamate ester;
oxazolidinone		metabolite
beta-lactams
2-azetidinone: structure in first source. azetidin-2-one : An unsubstituted beta-lactam compound.. beta-lactam : A lactam in which the amide bond is contained within a four-membered ring, which includes the amide nitrogen and the carbonyl carbon.		3.1410beta-lactam antibiotic allergen;
beta-lactam
linezolid
[no description available]		6.7933acetamides;
morpholines;
organofluorine compound;
oxazolidinone		antibacterial drug;
protein synthesis inhibitor
ro13-9904
Ceftriaxone: A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.. ceftriaxone : A third-generation cephalosporin compound having 2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetylamino and [(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl side-groups.		4.3711
daptomycin
[no description available]		2.0710
ceftobiprole
ceftobiprole: BAL5788 is Ceftobiprole medocaril sodium. ceftobiprole : A fifth-generation cephalosporin antibiotic having (E)-[(3'R)-2-oxo[1,3'-bipyrrolidin]-3-ylidene]methyl and [(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(hydroxyimino)acetyl]amino side groups located at positions 3 and 7 respectively; developed for the treatment of hospital-acquired pneumonia (HAP, excluding ventilator-associated pneumonia, VAP) and community-acquired pneumonia (CAP).		4.6340cephalosporin;
thiadiazoles		antimicrobial agent
ConditionIndicatedRelationship StrengthStudiesTrials
Community Acquired Infection
[description not available]		07.4851
Experimental Lung Inflammation
Inflammation of any part, segment or lobe, of the lung parenchyma.		04.0220
Pneumonia
Infection of the lung often accompanied by inflammation.		04.0220
Bacterial Pneumonia
[description not available]		010.66105
Pneumonia, Bacterial
Inflammation of the lung parenchyma that is caused by bacterial infections.		010.66105
Kidney Failure
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.		03.9520
Critical Illness
A disease or state in which death is possible or imminent.		03.9520
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		03.1210
Renal Insufficiency
Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.		03.9520
Ventilator-Associated Pneumonia
[description not available]		03.8920
Health Care Associated Infection
[description not available]		010.61104
Cross Infection
Any infection which a patient contracts in a health-care institution.		010.61104
Pneumonia, Ventilator-Associated
Serious INFLAMMATION of the LUNG in patients who required the use of PULMONARY VENTILATOR. It is usually caused by bacterial CROSS INFECTION in hospitals.		03.8920
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		03.8940
Infections, Staphylococcal
[description not available]		04.0650
Mediastinitis
Inflammation of the mediastinum, the area between the pleural sacs.		07.110
Staphylococcal Infections
Infections with bacteria of the genus STAPHYLOCOCCUS.		04.0650
Adverse Drug Event
[description not available]		03.0310
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		03.0310
Infections, Staphylococcal Skin
[description not available]		03.8320
Staphylococcal Skin Infections
Infections to the skin caused by bacteria of the genus STAPHYLOCOCCUS.		03.8320
Bacterial Infections, Gram-Negative
[description not available]		05.9631
Bacterial Meningitides
[description not available]		02.0710
Gram-Negative Bacterial Infections
Infections caused by bacteria that show up as pink (negative) when treated by the gram-staining method.		05.9631
Meningitis, Bacterial
Bacterial infections of the leptomeninges and subarachnoid space, frequently involving the cerebral cortex, cranial nerves, cerebral blood vessels, spinal cord, and nerve roots.		02.0710
Bacterial Endocarditides
[description not available]		02.0710
Endocarditis, Bacterial
Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.		02.0710
Foreign Bodies
Inanimate objects that become enclosed in the body.		02.0210
Primary Peritonitis
[description not available]		02.0310
Bacterial Infections, Gram-Positive
[description not available]		06.7342
Peritonitis
INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.		07.0310
Gram-Positive Bacterial Infections
Infections caused by bacteria that retain the crystal violet stain (positive) when treated by the gram-staining method.		06.7342
Bacterial Skin Diseases
[description not available]		05.3122
Skin Diseases, Bacterial
Skin diseases caused by bacteria.		05.3122
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		02.0410
Osteomyelitis
INFLAMMATION of the bone as a result of infection. It may be caused by a variety of infectious agents, especially pyogenic (PUS - producing) BACTERIA.		07.0410