drugset / Trial / NCT02349841
Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis
Phase 2
Completed
46 enrolled
TASK Applied Science
Barcelona Centre for International Health Research · collabEduardo Mondlane University · collabGlaxoSmithKline · collabResearch Center Borstel · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
To evaluate the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of meropenem administered intravenously three times a day, plus amoxycillin/CA administered orally three times a day; and of faropenem administered orally three times a day, plus amoxycillin/CA administered orally three times a day; for 14 consecutive days, in adult participants with newly diagnosed, smear positive pulmonary tuberculosis, in order to help establish proof-of-concept for carbapenem antibiotics as antituberculosis agents and to select the appropriate agent and route of administration for later stage clinical development.
Timeline
- Start
- 2014-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Faropenem | Small molecule | 600 mg | Oral |
| Subject | Meropenem | Small molecule | 2 g | Intravenous |
| Comparator | Rifafour e-275 | Unknown | — | Oral |
| Background | Amoxycillin/clavulanic acid | Unknown | 625 mg | Oral |