REMoxTB

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

Intervention

Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

Study Arms

• Placebo Comparator: Regimen 1 – 2EHRZ/4HR (control regimen)
• Experimental: Regimen 2 – 2MHRZ/2MHR
• Experimental: Regimen 3 – 2EMRZ/2MR

Primary Outcome Measures

• Combined failure of bacteriological cure and relapse within one year of completion of therapy as defined by culture using solid media.
• Proportion of patients with grade 3 or 4 adverse events (using a modified DAIDS scale of adverse event reporting)