Pharmacy and Poisons Board
Protocol No: ECCT/09/03/01 Date of Protocol: 18-08-2011
Study Title:

A randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol,
isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and
pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by
two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis
Study Objectives:
Laymans Summary:
Abstract of Study:

Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis (REMoxTB)

 

Official Title:

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

 

Sponsor:

Global Alliance for TB Drug Development

Collaborators:

European and Developing Countries Clinical Trials Partnership (EDCTP)

University College, London

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Sanofi

 

Site:  Centre for Respiratory Diseases Research, Kenya Medical Research Institute

Current standard TB therapy is based on four medicines discovered forty or more years ago that must be administered for six to eight months, often under the direct observation of a healthcare professional (DOTS). A shorter TB treatment regimen should increase patient compliance, reduce failure rates and lower TB-related healthcare expenditures in endemic countries. 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. Preclinical studies showed that moxifloxacin could reduce treatment time by two months when substituted for isoniazid or ethambutol, two cornerstones of current TB treatment. The results of clinical phase II studies support the treatment reduction potential of moxifloxacin. Moxifloxacin is currently approved in 123 countries for the treatment of acute bacterial infections. However, Moxifloxacin is not currently approved for the treatment of TB, including multi-drug resistant TB (MDR-TB).

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.

The study type is interventional and the study design is a randomized double blinded whose intervention model is parallel assignment and the primary purpose is to evaluate the treatment. The primary end points are efficacy and safety.

The study participants are patients with newly diagnosed previously untreated sputum smear positive pulmonary tuberculosis who fit the inclusion and exclusion criteria.

The study is ongoing but no recruitment of participants.