Phase 3
Completed N=138
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Community-acquired Pneumonia (CAP) · Hospital-acquired Pneumonia (HAP)
Source: ClinicalTrials.gov NCT03439124 ↗
Enrolled (actual)
138
Serious AEs
6.5%
Results posted
Sep 2020
Primary outcomePrimary: Adverse Events — 10; 5; 1; 0 Participants
◆ Published Evidence
Emerging
14citations · ~3 / year
A Phase 3, Randomized, Investigator-blinded Trial Comparing Ceftobiprole With a Standard-of-care Cephalosporin, With or Without Vancomycin, for the Treatment of Pneumonia in Pediatric Patients.
Summary
This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.
Linked Publications (2)
-
A Phase 3, Randomized, Investigator-blinded Trial Comparing Ceftobiprole With a Standard-of-care Cephalosporin, With or Without Vancomycin, for the Treatment of Pneumonia in Pediatric Patients.
-
Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
10; 5; 1; 0; 0; 0 | — |
| SECONDARY Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT) |
85; 43 | — |
| SECONDARY Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population |
80; 41 | — |
| SECONDARY Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population |
90; 41 | — |
| SECONDARY Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population |
84; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Male of female aged 3 months to 5 times the age-specific upper limit of normal;
- Creatinine clearance <50 mL/min/1.73 m²
- Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization
- History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin
- Poorly controlled seizure disorder
- Other exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03439124) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.