Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis (REMoxTB)
Pulmonary Tuberculosis
About this trial
This is an interventional treatment trial for Pulmonary Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
- Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
- Aged 18 years or over.
- No previous anti-tuberculosis chemotherapy.
- A firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period.
- Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 & 2).
- Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
Laboratory parameters performed up to 14 days before enrolment.
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal.
- Serum total bilirubin level less than 2.5 times upper limit of normal. Creatinine clearance (CrCl) level greater than 30 mls/min.
- Haemoglobin level of at least 7.0 g/dL.
- Platelet count of at least 50x109cells/L.
- Serum potassium greater than 3.5 mmol/L.
- Negative pregnancy test (women of childbearing potential).
Exclusion Criteria:
- Unable to take oral medication.
- Previously enrolled in this study.
- Received any investigational drug in the past 3 months.
- Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
- Any condition that may prove fatal during the first two months of the study period.
- TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
- Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease, blood disorders,peripheral neuritis, chronic diarrhoeal disease in which the current clinical condition of the patient is likely to prejudice the response to, or assessment of treatment.
- Pregnant or breast feeding.
- Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
- Contraindications to any medications in the study regimens.
- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine).
- Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
- Patients already receiving anti-retroviral therapy.
- Patients whose initial isolate is shown to be multiple drug resistant (i.e. resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or resistant to any fluoroquinolone)
- Weight less than 35kg
- HIV infection with CD4 count less than 250 cells/µL.
- End stage liver failure (class Child-Pugh C).
Sites / Locations
- Beijing Tuberculosis and Thoracic Tumor Research Institute
- Shanghai Pulmonary Hospital
- TB Institute
- Nirmal Kumar Jain
- Mahatma Gandhi Medical College& Hospital
- Ram-Tej Hospital,
- Siddharth Nursing Home,
- Rajul Nursing Home
- Varshneya Chest Clinic & Eye Care Centre
- Dr. Neeraj Gupta Clinic
- S.P.S Chauhan Clinic
- Dr. R. K. Garg's Clinic,
- Indra Nursing Home and Maternity Centre
- Dr. AK Singh Clinic
- Dr. S. K. Katiyar, Swaroop Nagar,
- Guru Tej Bahadur Hospital
- Dr. Komal Gupta
- New City Hospital and Trauma Centre,
- Surya Chest Foundation,
- Surya Kant Clinic
- Dr. Mahip Saluja Clinic, U.P.
- Arya Chest Clinic, UP,India
- Dr. S. P. Sondhi Clinic,
- Sri Ram Plaza
- Jigyasa Medical Center
- Saanvi MultiSpeciality Clinic,
- A-One Hospital
- Dr. D.K. Chauhan
- Centre for advanced lung and sleep disorders
- Dr. Mittal's clinic
- Diligent Hospital
- Ish Medical Centre and Respiratory Lab,
- Smt Prakash Devi Memorial Medical Centre,
- Centre for Respiratory Disease Research at KEMRI
- Institute of Respiratory Medicine (IPR) Jalan Pahang
- Hospital General de Occidente de la secretaria
- Madibeng centre for Research, 40 Pienaar Street,
- Clinical HIV Research Unit (CHRU)
- Centre for TB Research and Innovation, University of Cape Town Lung Institute
- Tiervlei Trial Center and University of Stellenbosch
- Unit for Clinical & Biomedical TB Research, MRC Durban
- NIMR Mbeya Medical Research Programme
- Kilimanjaro Christian Medical Centre
- Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
- Chest Disease Institute (CDI), Ministry of Public,
- Rajavithi Hospital, Division Of Pulmonary Medicine
- University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Regimen 1 - 2EHRZ/4HR (control regimen)
Regimen 2 - 2MHRZ/2MHR
Regimen 3 - 2EMRZ/2MR
Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by Nine weeks of Isoniazid and Rifampicin only.
Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by Nine weeks of the Isoniazid placebo and the Rifampicin placebo