Overview

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

Status:
Completed

Trial end date:
2014-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

TASK Applied Science
Task Foundation NPC

Collaborators:

Barcelona Centre for International Health Research
Eduardo Mondlane University
GlaxoSmithKline
Research Center Borstel
University Eduardo Mondlane

Treatments:

Amoxicillin
beta-Lactams
Clavulanic Acid
Clavulanic Acids
Meropenem
Thienamycins