Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

Phase 2 Completed 69 enrolled Global Alliance for TB Drug Development

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

Timeline

Start: 2009-08
Primary completion: 2010-01
Completion: 2010-05

Publications

Results Diacon AH, Dawson R, du Bois J, Narunsky K, Venter A, Donald PR, van Niekerk C, Erondu N, Ginsberg AM, Becker P, Spigelman MK. Phase II dose-ranging trial of the early bactericidal activity of PA-824. Antimicrob Agents Chemother. 2012 Jun;56(6):3027-31. doi: 10.1128/AAC.06125-11. Epub 2012 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pretomanid	Small molecule	50 mg	Oral
Subject	Pretomanid	Small molecule	100 mg	Oral
Subject	Pretomanid	Small molecule	150 mg	Oral
Subject	Pretomanid	Small molecule	200 mg	Oral
Comparator	Rifafour e-275	Unknown	275 mg	—

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

Summary

Timeline

Publications

Drugs

Indications