CTRI/2008/091/000024.

Trial name or title	Randomized clinical trial to study the efficacy and tolerability of 3‐ and 4‐month regimens containing moxifloxacin in the treatment of patients with sputum smear and culture positive pulmonary tuberculosis
Methods	Randomized, open‐label, parallel‐group, 5‐arm, active‐controlled trial
Participants	Inclusion criteria: Age 18 years to 60 years Residing in or around Chennai or Madurai No previous anti‐tuberculosis treatment At least 2 sputum smears should be positive for tubercle bacilli by fluorescent microscopy at enrolment Willing to attend the treatment centre for supervised treatment Willing for home visits by staff from the centre Willing to give written informed consent Exclusion criteria: Body weight less than 30 kg Hepatic or renal disease as evidenced by clinical or biochemical abnormalities Diabetes mellitus History of seizure or loss of consciousness Psychiatric illness Abnormal electrocardiogram or anti‐arrhythmic medication Those in a moribund state Seropositive for HIV antibodies Pregnancy or lactation Visual disorders other than refractory error Anticipated sample size: 1650
Interventions	Intervention(s): Moxifloxacin arm: 4 regimens of 3 to 4 months 3 RHZEM 2 RHZEM/2 RHM 2 RHZEM/2 RHM thrice weekly 2 RHZEM/2 RHEM thrice weekly Dose: rifampicin 450 mg; isoniazid 300 mg (daily), 600 mg (thrice weekly); pyrazinamide 1500 mg; ethambutol 800 mg (daily), 1200 mg (thrice weekly); moxifloxacin 400 mg Control: 2 RHZE thrice weekly/4 RH thrice weekly (for 6 months) Dose: rifampicin 450 mg; isoniazid 600 mg; pyrazinamide 1500 mg; ethambutol 1200 mg
Outcomes	Primary outcome: Relapse rates 24 months after treatment among those with a favourable or doubtful bacteriologic response at end of treatment Secondary outcomes: Sputum culture conversion at 2 months of treatment Bacteriologic response at end of treatment Adverse reactions to anti‐tuberculosis drugs during treatment
Starting date	30 May 2007; anticipated study end date: May 2015; no results posted (last modified 06/02/2013)
Contact information	Dr MS Jawahar, Tuberculosis Research Centre, Mayor VR Ramanathan Road, Chetput, Chennai TAMIL NADU 600031 India. Tel: +91‐44‐28369500; Email: msjawahar@trcchennai.in
Notes	Study locations: Chennai and Madurai in India Registration number:CTRI/2008/091/000024 Primary sponsor: Indican Council of Medical Research Comment: the first author confirmed that this is completed, has been analysed, written up, submitted for publication, and will be re‐submitted after peer review