This is 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.
Purpose
The commonly used drugs to treat tuberculosis are rifampicin, isoniazid, ethambutol and pyrazinamide. Standard therapy consists of a combination of all four drugs for 2 months followed by a 4 months period of rifampicin and isoniazid combined. Previous studies in animals and in humans suggest that a new drug called moxifloxacin may also be an effective treatment in tuberculosis. Moreover, promising laboratory studies on mice suggest that moxifloxacin may enable the total duration of chemotherapy to be reduced to four months, which would be a significant improvement for patients taking medication for tuberculosis.
Team
MMRC: Dr. Leonard Maboko (site principal investigator), Dr. Chacha Mangu (clinical research coordinator, study clinician), Dr. Andrea Rachow (study coordinator), Dr. Issa Sabi (study clinician), Dr. Denis Ngatemelela (study clinician), Ruth Bakuza (study secretary), Sophie Hyera (counsellor, medical officer), Magreth Sembo (counsellor, medical officer), Jane Abindwhile (social scientist), Revocatus Kunambi (pharmacist), Theopista Lotto (back-up pharmacist), Dickens Kuwour (senior data manager), Sosten Buromo (senior data entry officer), Happy Shimwela (driver), Patrick Hamisi Chaula (driver), Rahabu Mkandawile (courier).
LMU: Dr. Michael Hoelscher (scientific director), Dr. Norbert Heinrich (study coordinator), Bettina Rademacher (head of project administration and finance).
Approach
REMoxTB is 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.
Patients selected for the study will be allocated to one of three treatment groups. The first group will be given six months standard treatment. A second group will receive moxifloxacin substituted for ethambutol, as part of a four month regimen, to see whether the shorter treatment is as effective as the standard six month treatment. The third group will receive moxifloxacin substituted for isoniazid, as part of a four month regimen, to see whether the shorter treatment is as effective as the standard six month treatment.
During and after receiving study treatment the study patients are reviewed for adverse events and clinical outcome. Sputum samples are collected at each study visit for preparation of sputum smear and culture and other investigations (e.g. treatment marker). The follow up period lasts for 12 months after finishing of study treatment.
Results
Since the study is still ongoing final results are not yet available.
Sponsor
This worldwide multicenter phase 3 treatment trial is sponsored by the EDCTP and Global TB Alliance.
Partners
1. Pan African Consortium for Evaluation of Anti TB Treatment (PanACEA), founded by three European universities (Ludwig Maximilian University, Munich in Germany, University College of London Great Britain, University St. Radboud, Nijmegen in the Netherlands) who are collaborating with 10 African study sites to accelerate clinical development of new anti-tuberculosis drugs, meeting international quality standards.
2. Global TB-Alliance
3. Triclinium, Clinical Trial Project Management (PTY) LTD
Publications
