The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as well as the possible adverse effects of its long-term use, it is rational to use linezolid instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB. Through randomized controlled trial, the investigators will evaluate the hypothesis that the use of linezolid instead of ethambutol will increase the sputum culture conversion rate by 15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2 (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment (liquid media).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
429
Seoul National University Bundang Hospital
Seongnam, Kyunggi, South Korea
RECRUITINGNational Medical Center
Seoul, Seoul, South Korea
RECRUITINGSMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
RECRUITINGSputum culture conversion rate on liquid media
Time frame: after 2 months of treatment
Sputum culture conversion rate on solid media
Time frame: after 2 months of treatment
Time to sputum culture conversion (liquid and solid media)
Time frame: During 6 months of treatment
Cure rate
Time frame: After 6 months of treatment
Treatment success rate
Time frame: after 6 months of treatment
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