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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Delamanid for multidrug-resistant pulmonary tuberculosis
New England Journal of Medicine, Volume 366, No. 23, Year 2012
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Description
BACKGROUND: Delamanid (OPC-67683), a nitro-dihydro-imidazooxazole derivative, is a new anti-tuberculosis medication that inhibits mycolic acid synthesis and has shown potent in vitro and in vivo activity against drug-resistant strains of Mycobacterium tuberculosis. METHODS: In this randomized, placebo-controlled, multinational clinical trial, we assigned 481 patients (nearly all of whom were negative for the human immunodeficiency virus) with pulmonary multidrug-resistant tuberculosis to receive delamanid, at a dose of 100 mg twice daily (161 patients) or 200 mg twice daily (160 patients), or placebo (160 patients) for 2 months in combination with a background drug regimen developed according to World Health Organization guidelines. Sputum cultures were assessed weekly with the use of both liquid broth and solid medium; sputum-culture conversion was defined as a series of five or more consecutive cultures that were negative for growth of M. tuberculosis. The primary efficacy end point was the proportion of patients with sputum-culture conversion in liquid broth medium at 2 months. RESULTS:Among patients who received a background drug regimen plus 100 mg of delamanid twice daily, 45.4% had sputum-culture conversion in liquid broth at 2 months, as compared with 29.6% of patients who received a background drug regimen plus placebo (P = 0.008). Likewise, as compared with the placebo group, the group that received the background drug regimen plus 200 mg of delamanid twice daily had a higher proportion of patients with sputum-culture conversion (41.9%, P = 0.04). The findings were similar with assessment of sputum-culture conversion in solid medium. Most adverse events were mild to moderate in severity and were evenly distributed across groups. Although no clinical events due to QT prolongation on electrocardiography were observed, QT prolongation was reported significantly more frequently in the groups that received delamanid. CONCLUSIONS: Delamanid was associated with an increase in sputum-culture conversion at 2 months among patients with multidrug-resistant tuberculosis. This finding suggests that delamanid could enhance treatment options for multidrug-resistant tuberculosis. (Funded by Otsuka Pharmaceutical Development and Commercialization; ClinicalTrials. gov number, NCT00685360.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Gler, Maria Tarcela S.
Philippines, Makati
Makati Medical Center
Philippines, Manila
Tropical Disease Foundation
Skripčonoka, Vija
Latvia, Riga
State Agency of Tuberculosis and Lung Diseases
Sánchez Garavito, Epifanio
Peru, Lima
Hospital Nacional Sergio E. Bernales
Xiao, Heping
China, Shanghai
Shanghai Pulmonary Hospital
Cabrera-Rivero, Jose L.
Peru, Lima
Hospital Nacional Daniel Alcides Carrión
Vargas, Dante
Peru, Lima
Hospital Nacional Hipólito Unanue
Gao, Mengqiu
China, Beijing
Beijing Chest Hospital, Capital Medical University
Tageldin, Mohamed Awad
Egypt, Cairo
Sadr Abassia Hospital
Park, Seungkyu
South Korea, Masan
National Masan Hospital
Shim, Tae-sun
South Korea, Seoul
Asan Medical Center
Suh, Gee-young
South Korea, Seoul
Samsung Medical Center, Sungkyunkwan University
Danilovitš, Manfred
Estonia, Tartu
Tartu Ülikooli Kliinikum
Ogata, Hideo
Japan, Kiyose
Fukujuji Hospital
Kurve, Anu
Estonia, Tallinn
North Estonia Medical Centre
Chang, Joon
South Korea, Seoul
Yonsei Medical Research Center
Suzuki, Katsuhiro
Japan, Sakai
National Hospital Organization Kinki-chuo Chest Medical Center
Tupasi, Thelma E.
Philippines, Makati
Makati Medical Center
Koh, Wonjung
South Korea, Seoul
Samsung Medical Center, Sungkyunkwan University
Seaworth, Barbara
United States, Tyler
University of Texas Health Center at Tyler
Geiter, Lawrence J.
United States, Rockville
Opdc
Wells, Charles D.
United States, Rockville
Opdc
Statistics
Citations: 633
Authors: 21
Affiliations: 19
Identifiers
Doi:
10.1056/NEJMoa1112433
ISSN:
00284793
e-ISSN:
15334406