Phase 3
N=138
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Community-acquired Pneumonia (CAP) · Hospital-acquired Pneumonia (HAP)
Bottom Line
View on ClinicalTrials.gov: NCT03439124 ↗Enrolled (actual)
138
Serious AEs
6.5%
Results posted
Sep 2020
Primary outcome: Primary: Adverse Events — 10; 5; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ceftobiprole medocaril (Drug); IV standard-of-care cephalosporin (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Mar 2020
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 | — |
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.
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). 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.