NCT02901288.

Trial name or title	Shortened regimens for drug‐susceptible pulmonary tuberculosis
Methods	Multi‐centre, randomized, non‐inferiority, open‐label, controlled phase 3 clinical trial
Participants	Patients with newly diagnosed drug‐susceptible pulmonary TB who fulfil the inclusion and exclusion criteria Inclusion criteria: Willing and able to give informed consent to participate in trial treatment and follow‐up Aged 18 to 65 years Twice positive acid‐fast bacilli (AFB) sputum smear or positive sputum culture result, along with chest X‐ray consistent with active pulmonary tuberculosis Newly diagnosed cases receiving anti‐tuberculosis treatment for < 1 month Urine human chorionic gonadotropin (U‐HCG) negative and must agree to use effective contraception during trial period Alanine aminotransferase (ALT) and total bilirubin < 2 times upper limit of normal Creatinine clearance rate > 30 mL/min Haemoglobin > 7.0 g/dL Platelets > 50 x 10⁹/L Exclusion criteria: Concomitant severe cardiovascular, liver, kidney, nervous system, haematopoietic system, and other disease, or concomitant neoplastic disease. Or extensive lesion with respiratory insufficiency Uncontrolled diabetes mellitus Concomitant mental disorder HIV‐positive individuals Critically ill patients Pregnant or breastfeeding mothers Unable or unwilling to comply with treatment, assessment, or follow‐up schedule Taking any medications contraindicated with medicines in any trial regimen of the study Known allergy to any drug of treatment regimens Currently taking part in another trial QTc interval > 480 ms Anticipated sample size: 3900 (1300 in each group)
Interventions	Interventions: Levofloxacin + ethambutol 4.5‐month combination ATT regimen 4.5 months of isoniazid, rifampin, pyrazinamide, ethambutol, and levofloxacin Dosage: isoniazid 300 mg (given once daily), rifampin 450 mg (less than 50 kg given once daily) or 600 mg (more than 50 kg given once daily), pyrazinamide 1500 mg ((less than 50 kg given once daily) or 30 mg/kg (more than 50 kg once daily), ethambutol 750 mg (less than 50 kg once daily) or 1000 mg (more than 50 kg once daily), levofloxacin 600 mg (less than 50 kg given once daily) or 800 mg (more than 50 kg once daily) Ethambutol 4.5‐month combination ATT regimen 4.5 months of isoniazid, rifampin, pyrazinamide, and ethambutol. Dosage of isoniazid, rifampin, pyrazinamide, and ethambutol is same as that of control regimen Control: Standard 6‐month ATT regimen 2 months of isoniazid, rifampin, pyrazinamide, and ethambutol, followed by 4 months of isoniazid and rifampin Dosage: isoniazid 300 mg (given once daily), rifampin 450 mg (less than 50 kg given once daily) or 600 mg (more than 50 kg given once daily), pyrazinamide 1500 mg (less than 50 kg given once daily) or 30 mg/kg (more than 50 kg once daily), ethambutol 750 mg (less than 50 kg once daily), or 1000 mg (more than 50 kg, once daily)
Outcomes	Primary outcome measures: Percentage of participants with TB recurrence/relapse by 24 months after end of treatment Percentage of participants with treatment failure at 4.5 months or 6 months after randomization Secondary outcome measures: Treatment adverse reactions occurring Time to sputum smear or culture conversion within intensive phase Sputum smear or culture conversion proportion at treatment completion Radiological manifestation change in TB lesion or cavity Patient adherence rate
Starting date	August 2016; estimated study completion date: December 2018
Contact information	Shenjie Tang, MD. Beijing Chest Hospital Email: tangsj1106@sina.com
Notes	Study location: China Registration number:NCT02901288 Primary sponsors: Beijing Chest Hospital, Hubei Provincial Center for Disease Control and Prevention

Abbreviations: AFB: acid‐fast bacilli; ALP: alkaline phosphatase; ALT: alanine aminotransferase; ART: antiretroviral therapy; ARV: antiretroviral; AST: aspartate aminotransferase; ATT: anti‐tuberculosis treatment; CrCl: creatinine clearance; E: ethambutol; ECG: electrocardiogram; FSH: follicle‐stimulating hormone; H: isoniazid; HbA1c: glycosylated haemoglobin; IUCD: intrauterine coil device; LH: luteinizing hormone; M: moxifloxacin; MDR‐TB: multi‐drug‐resistant tuberculosis; MGIT: mycobacterial growth indicator tube; MIC: minimum inhibitory concentration; MTB: Mycobacterium tuberculosis; PK: pharmacokinetics; R: rifampicin; TB: tuberculosis; TEAE: treatment‐emergent adverse event; TTP: time to positivity; U‐HCG: urine human chorionic gonadotropin; ULN: upper limit of normal; WHO: World Health Organization; XDR: extensively drug‐resistant; Z: pyrazinamide.