Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
Status:
Unknown status
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
Seoul National University Hospital
Collaborators:
Ministry of Health & Welfare, Korea Pfizer Seoul National University Bundang Hospital SMG-SNU Boramae Medical Center