Tuberculosis, Pulmonary Clinical Trial
Official title:
Shortened Regimens for First Diagnosed Smear Positive Drug Susceptible Pulmonary Tuberculosis: a Randomised Controlled Non-inferiority Trial
The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen.
1. Design: The study is a multi-center, randomized,controlled non-inferiority trial.
2. Population: patients with newly diagnosed drug-susceptible pulmonary TB who fulfill the
inclusion and exclusion criteria.
3. Investigational regimens:
Experimental group 1 regimen consists of levofloxacin, isoniazid ,
rifampicin,ethambutol and pyrazinamide for 4.5 months.
Experimental group 2 regimen consists of isoniazid, rifampicin, ethambutol and
pyrazinamide for 4.5 months.
The control group is WHO recommended regimen conmposed of isoniazid , rifampicin,
ethambutol and pyrazinamide for 2 months, followed by isoniazid , rifampicin for 4
months.
Dosage: isoniazid 300mg(given once daily), rifampin 450mg(less than 50kg,given once
daily)or 600mg(more than 50kg,given once daily), pyrazinamide 1500mg(less than
50kg,given once daily)or 30mg/kg(more than 50kg,once daily), ethambutol 750mg (less
than 50kg,once daily) or 1000mg (more than 50kg,once daily), levofloxacin 600mg(less
than 50kg,given once daily) or 800mg(more than 50kg,once daily)..
4. Trial objectives: to evaluate that shortened regimens is not inferior to standard
treatment in terms of efficacy and safety for new smear positive pulmonary TB patients.
5. Primary and Secondary outcome measures:
The primary efficacy outcome measures include (a)the percentage of participants with TB
recurrence/relapse by 24 months after the end of treatment;(b) percentage of
participants with treatment failure at either 4.5 months or 6 months after
randomization. (a) Time to sputum smear or culture conversion within intensive
phase.(b) Sputum smear conversion proportion at the treatment completion. (c) Number of
adverse drug reaction occurring during treatment or follow-up period. (d) Radiological
manifestation change of TB lesion or cavity.(e) Patients adherence rate.
6. Sample Size:
Approximately 3900 participants will be enrolled and randomized with 1:1:1 ratio into
either Experimental group1, Experimental group2 or control group.
7. Blinding:
The study is an open-label study.
8. Assessment and follow-up:
All patients will be followed by to 2 years after completion of treatment.
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