CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Moxifloxacindrug
Likely dose
Moxifloxacin 400mg daily for 8 weeksAI-extracted
Key inclusion· 2
  • ✓Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry; patients with concurrent pulmonary and extrapulmonary disease are eligible.
  • ✓Documented HIV infection status or consent to testing with results available before enrollment.
Key exclusion· 8
  • ✕History of adverse drug reaction to moxifloxacin, INH, RIF, PZA, or EMB.
  • ✕More than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever.
  • ✕Active AIDS-related opportunistic infection or malignancy.
  • ✕Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082173
NCT00082173Phase 2Completed
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Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection

Johns Hopkins University·interventional·Posted May 4, 2004·Updated May 22, 2013

In Brief

A Phase 2 clinical trial evaluating Moxifloxacin for Tuberculosis. Completed, enrolled 170 participants across 1 site.

Detailed Summary

Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesBrazil
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2004
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2007
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 22.2 years ago

Interventions

Moxifloxacindrug

400mg daily for 8 weeks