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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Linezolid for treatment of chronic extensively drug-resistant tuberculosis
New England Journal of Medicine, Volume 367, No. 16, Year 2012
Notification
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Description
BACKGROUND: Linezolid has antimycobacterial activity in vitro and is increasingly used for patients with highly drug-resistant tuberculosis. METHODS: We enrolled 41 patients who had sputum-culture-positive extensively drug-resistant (XDR) tuberculosis and who had not had a response to any available chemotherapeutic option during the previous 6 months. Patients were randomly assigned to linezolid therapy that started immediately or after 2 months, at a dose of 600 mg per day, without a change in their background regimen. The primary end point was the time to sputum-culture conversion on solid medium, with data censored 4 months after study entry. After confirmed sputum-smear conversion or 4 months (whichever came first), patients underwent a second randomization to continued linezolid therapy at a dose of 600 mg per day or 300 mg per day for at least an additional 18 months, with careful toxicity monitoring. RESULTS: By 4 months, 15 of the 19 patients (79%) in the immediate-start group and 7 of the 20 (35%) in the delayed-start group had culture conversion (P = 0.001). Most patients (34 of 39 [87%]) had a negative sputum culture within 6 months after linezolid had been added to their drug regimen. Of the 38 patients with exposure to linezolid, 31 (82%) had clinically significant adverse events that were possibly or probably related to linezolid, including 3 patients who discontinued therapy. Patients who received 300 mg per day after the second randomization had fewer adverse events than those who continued taking 600 mg per day. Thirteen patients completed therapy and have not had a relapse. Four cases of acquired resistance to linezolid have been observed. CONCLUSIONS: Linezolid is effective at achieving culture conversion among patients with treatment-refractory XDR pulmonary tuberculosis, but patients must be monitored carefully for adverse events. (Funded by the National Institute of Allergy and Infectious Diseases and the Ministry of Health and Welfare, South Korea; ClinicalTrials.gov number, NCT00727844.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Lee, Myungsun
South Korea, Changwon
International Tuberculosis Research Center
Lee, Jongseok
South Korea, Changwon
International Tuberculosis Research Center
Carroll, Matthew W.
United States, Bethesda
National Institutes of Health Nih
Choi, Hongjo
South Korea, Changwon
International Tuberculosis Research Center
Song, Taeksun
South Korea, Changwon
International Tuberculosis Research Center
Via, L. E.
United States, Bethesda
National Institutes of Health Nih
Goldfeder, Lisa C.
United States, Bethesda
National Institutes of Health Nih
Jeon, Han-seung
South Korea, Changwon
International Tuberculosis Research Center
Joh, Joonsung
Unknown Affiliation
Chen, Ray Y.
United States, Bethesda
National Institutes of Health Nih
Olivier, Kenneth N.
United States, Bethesda
National Institutes of Health Nih
Shaw, Pamela A.
United States, Bethesda
National Institutes of Health Nih
Follmann, Dean A.
United States, Bethesda
National Institutes of Health Nih
Lee, Jong-koo
South Korea, Seoul
Seoul National University Hospital
Dartois, Véronique A.
Singapore, Singapore City
Novartis Institute for Tropical Diseases Pte. Ltd.
Park, Seungkyu
South Korea, Masan
National Masan Hospital
Cho, Sangnae Ray
South Korea, Seoul
Yonsei University College of Medicine
Barry, Clifton Earl
United States, Bethesda
National Institutes of Health Nih
Statistics
Citations: 512
Authors: 18
Affiliations: 7
Identifiers
Doi:
10.1056/NEJMoa1201964
ISSN:
00284793
Study Design
Randomised Control Trial