drugset / Trial / NCT02605122
Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
Phase 2/3
Terminated
97 enrolled
Melinta Therapeutics, Inc.
Biomedical Advanced Research and Development Authority · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
Timeline
- Start
- 2016-04
- Primary completion
- 2018-03-21
- Completion
- 2018-03-21
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped: “Development not proceeding”
registry No p-value was performed. NCT02605122 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | — | Intravenous |
| Comparator | Amoxicillin clavulanic acid | Unknown | — | Oral |
| Comparator | Ampicillin | Small molecule | — | Intravenous |
| Comparator | Azithromycin | Small molecule | — | — |
| Comparator | Ceftriaxone | Other / unclassified | — | Intravenous |
| Comparator | Erythromycin | Small molecule | — | — |
| Subject | Solithromycin | Other / unclassified | — | Oral |