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Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)

NCT01215110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-04-26

Study results available
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Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

TMC207

DRUG

Rifafour e-275 mg

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Andreas Diacon · TASK APPLIED SCIENCE, Karl Bremer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • South Africa

Study Locations

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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 NCT01215110 on ClinicalTrials.gov