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

NCT00944021 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-09-20

Study results available
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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.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

PA-824

50mg

DRUG

PA-824

100mg

DRUG

PA-824

150 mg

DRUG

Rifafour e-275 mg

275 mg

DRUG

PA-824

200 mg

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Andreas Diacon, MD · Karl Bremer Hospital

  • Rodney Dawson, MD · University of Cape Town Lung Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-01-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944021 on ClinicalTrials.gov