{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T10:25:31Z","timestamp":1773311131634,"version":"3.50.1"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2025,6,6]],"date-time":"2025-06-06T00:00:00Z","timestamp":1749168000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["5\/8\/5\/39\/2018\/ECD-1"],"award-info":[{"award-number":["5\/8\/5\/39\/2018\/ECD-1"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Clofazimine, an antimycobacterial agent, has demonstrated efficacy in reducing the treatment duration for MDR TB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To determine whether a 16 week clofazimine-based regimen is non-inferior to the standard 24 week regimen for drug-susceptible pulmonary TB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>CORTAIL was a multicentric, investigator-initiated, randomized controlled trial designed to assess the non-inferiority of a 16 week clofazimine-based regimen compared with the standard 24 week regimen for drug-susceptible pulmonary TB (Clinical Trials Registry of India no. CTRI\/2019\/03\/018102). In the intervention arm, clofazimine replaced ethambutol during both the intensive and continuation phases of treatment. The primary outcome was relapse at the end of 3 month follow-up after treatment completion.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Across 11 centres, a total of 161 patients were randomized to the standard regimen and 161 patients received the shorter regimen. Relapse was observed in 1.9% patients in the standard group and 3.2% in the shorter regimen, the difference lying within the predefined non-inferiority margin [relative risk (RR) 1.65; 95% CI 0.444\u20136.19; P\u200a=\u200a0.723; adjusted risk (AR) 1.2%; 95% CI \u22123.3% to 6.1%]. Key secondary outcome of relapse at 1 year was also not significantly different between the two groups (RR 1.31; 95% CI 0.58\u20132.95; P\u200a=\u200a0.652; AR 1.8%; 95% CI \u22124.5% to 8.2%). The proportion of patients achieving sputum smear negativity (RR 1.59; 95% CI 0.69\u20133; P\u200a=\u200a0.36; AR 3.1%; 95% CI \u22123.2% to 9.5%) and bacteriological cure (RR 1.03; 95% CI 0.57\u20131.88; P\u200a=\u200a0.99; AR 0.4%; 95% CI \u22127.4% to 8.2%) by the end of treatment was similar between the two treatment arms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A clofazimine-based 16 week regimen was found to be safe and non-inferior to the currently available 24 week regimen.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkaf176","type":"journal-article","created":{"date-parts":[[2025,6,6]],"date-time":"2025-06-06T10:40:07Z","timestamp":1749206407000},"page":"2100-2108","source":"Crossref","is-referenced-by-count":1,"title":["Four-month clofazimine regimen for susceptible pulmonary TB: a randomized clinical trial"],"prefix":"10.1093","volume":"80","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7053-003X","authenticated-orcid":false,"given":"Nusrat","family":"Shafiq","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Clinical Pharmacology Unit, Postgraduate Institute of Medical Education and Research (PGIMER) , Chandigarh 160012 ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashok","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER) , Chandigarh 160012 ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikram","family":"Vohra","sequence":"additional","affiliation":[{"name":"Department of Tuberculosis and Respiratory Diseases, National Institute of Tuberculosis and Respiratory Diseases (NITRD) , Sri Aurobindo Marg, Delhi 110030 ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gopal Krishan","family":"Khuller","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Postgraduate Institute of Medical Education and Research (PGIMER) , Chandigarh 160012 ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manjula","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of ECD, Indian Council of Medical Research (IMCR) , New Delhi ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amandeep","family":"Kaur","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER) , Chandigarh 160012 ,","place":["India"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Narinder","family":"Gulati","sequence":"additional","affiliation":[{"name":"Department of Chest Diseases and Respiratory Medicine, 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