Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140309
Status:
COMPLETED
Last Update Posted:
2007-03-19
First Post:
2005-08-30
Brief Title:
TBTC Study 27 Moxifloxacin vs Ethambutol for TB Treatment
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None