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Table 1 Eligibility criteria

From: Efficacy of ultra-short course chemotherapy for new smear positive drug susceptible pulmonary tuberculosis: study protocol of a multicenter randomized controlled clinical trial

Inclusion criteria

Exclusion criteria

Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate)

Is HIV positive

Is aged of 18–65 years old

Is concomitant with mental disorders

Is previously untreated or treated less than 1 month with anti-TB drugs

Is concomitant with diabetes while mellitus blood glucose out of control

Has 2 positive sputum smear results for mycobacterium TB at screening

Is pregnant or breastfeeding

Has a chest X-ray abnormality compatible with a diagnosis of PTB

Has a prolonged QTcFa (>480 ms)

Is not pregnant for female patient at bearing age and willing to use effective contraception during study period

Is currently participate in another trial of a medicinal product

Has CrClb > 30 ml/ min, HBc > 7.0 g/dL and PLTd > 50 × 109/L at screening

Is concomitant with severe cardiovascular, hepatic, renal, nervous system, hematopoietic system injury and other diseases, or concomitant with neoplastic diseases

Has ALTe and TBILf less than 2 times the upper limit of normal at screening

Has extensive lesion in the lung concomitant with respiratory insufficiency

 

Has known allergy to any of the anti-TB drugs in the trial

 

Is taking any medications contraindicated with the medicines in any trial regimen of the study

  1. a QTcF Fridericia-corrected QT, b CrCl creatinine clearance, c HB hemoglobin, d PLT Platelet, e ALT alanine aminotransferase, f TBIL total bilirubin