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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Global Alliance for TB Drug Development
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma; European and Developing Countries Clinical Trials Partnership (EDCTP); Sanofi; University College, London
• Treatments: Ethambutol; Fluoroquinolones; Isoniazid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pyrazinamide; Rifampin

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).