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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00140309 |
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.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis, Pulmonary |
Drug: moxifloxacin (with isoniazid, rifampin, pyrazinamide) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 350 |
Study Start Date: | July 2003 |
Study Completion Date: | December 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory parameters within 14 days of enrollment:
Exclusion Criteria:
Principal Investigator: | William Burman, MD | Denver Public Health Department |
Principal Investigator: | Richard E Chaisson, MD | Johns Hopkins University |
Study ID Numbers: | CDC-NCHSTP-3716 |
Study First Received: | August 30, 2005 |
Last Updated: | March 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00140309 |
Health Authority: | United States: Food and Drug Administration |
TB Pulmonary Tuberculosis Tuberculosis Pulmonary TB |
Bacterial Infections Pyrazinamide Rifampin Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin |
Lung Diseases Tuberculosis, pulmonary Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Ethambutol Isoniazid |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses |
Antitubercular Agents Pharmacologic Actions Actinomycetales Infections |