At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis
In Brief
A Phase 3 clinical trial evaluating Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin for Pulmonary Tuberculosis. Completed, enrolled 1,931 participants across 47 sites in 9 countries.
Detailed Summary
REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.
Study Details
Timeline
Interventions
Moxifloxacin 400 mg Rifampicin \< 45 kg 450 mg \> 45 kg 600 mg Isoniazid 300 mg Pyrazinamide \< 40 kg 25 mg/kg rounded to nearest 500 mg\* 40-55 kg 1000 mg \> 55 kg - 75 kg 1500 mg \> 75 kg 2000 mg Ethambutol \< 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg \> 55 kg - 75 kg 1200 mg \> 75 kg 1600 mg \*For pyrazinamide dosing in patients \< 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.