NCT00140309

TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

TBTC Study 27: An Evaluation of the Activity and Tolerability of Moxifloxacin During the First Two Months of Treatment for Pulmonary Tuberculosis--A Double-Blind, Randomized, Multicenter Study by the Tuberculosis Trials Consortium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.

Detailed description

The primary objective of this Phase II clinical trial is to compare the safety and microbiological activity of a moxifloxacin-containing regimen (isoniazid, rifampin, pyrazinamide, moxifloxacin \[HRZMoxi\]) to a control regimen (isoniazid, rifampin, pyrazinamide, ethambutol \[HRZE\]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis. In addition, the study will evaluate whether intermittent administration (thrice-weekly after the first 2 weeks) of these regimens affects their tolerability and microbiological activity. The assessment of microbiological activity will be sputum culture-conversion. Improved sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen would support phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	moxifloxacin (with isoniazid, rifampin, pyrazinamide)

Timeline

• Start date: 2003-07-01
• Completion: 2005-12-01
• First posted: 2005-09-01
• Last updated: 2007-03-19

Locations

23 sites across 4 countries: United States, Canada, South Africa, Uganda