drugset / Trial / NCT03439124
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2017-11-27
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
Publications
- Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296.
- Bosheva M, Gujabidze R, Karoly E, Nemeth A, Saulay M, Smart JI, Hamed KA. 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. Pediatr Infect Dis J. 2021 Jun 1;40(6):e222-e229. doi: 10.1097/INF.0000000000003077.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ceftazidime | Small molecule | — | Intravenous |
| Subject | Ceftobiprole medocaril | Small molecule | 10 mg/kg | Intravenous |
| Subject | Ceftobiprole medocaril | Small molecule | 15 mg/kg | Intravenous |
| Subject | Ceftobiprole medocaril | Small molecule | 20 mg/kg | Intravenous |
| Comparator | Ceftriaxone | Other / unclassified | 50 mg/kg | Intravenous |
| Comparator | Ceftriaxone | Other / unclassified | 80 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 10 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |