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Multidrug-resistant tuberculosis and culture conversion with bedaquiline

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dc.contributor.author Diacon, Andreas H.
dc.contributor.author Pym, Alexander
dc.contributor.author Grobusch, Martin P.
dc.contributor.author De Los Rios, Jorge M.
dc.contributor.author Gotuzzo Herencia, José Eduardo
dc.contributor.author Vasilyeva, Irina
dc.contributor.author Leimane, Vaira
dc.contributor.author Andries, Koen
dc.contributor.author Bakare, Nyasha
dc.contributor.author De Marez, Tine
dc.contributor.author Haxaire-Theeuwes, Myriam
dc.contributor.author Lounis, Nacer
dc.contributor.author Meyvisch, Paul
dc.contributor.author De Paepe, Els
dc.contributor.author Van Heeswijk, Rolf P.G.
dc.contributor.author Dannemann, Brian
dc.date.accessioned 2020-06-10T18:12:14Z
dc.date.available 2020-06-10T18:12:14Z
dc.date.issued 2014
dc.identifier.uri https://hdl.handle.net/20.500.12866/8066
dc.description.abstract BACKGROUND: Bedaquiline (Sirturo, TMC207), a diarylquinoline that inhibits mycobacterial ATP synthase, has been associated with accelerated sputum-culture conversion in patients with multidrug-resistant tuberculosis, when added to a preferred background regimen for 8 weeks. METHODS: In this phase 2b trial, we randomly assigned 160 patients with newly diagnosed, smear-positive, multidrug-resistant tuberculosis to receive either 400 mg of bedaquiline once daily for 2 weeks, followed by 200 mg three times a week for 22 weeks, or placebo, both in combination with a preferred background regimen. The primary efficacy end point was the time to sputum-culture conversion in liquid broth. Patients were followed for 120 weeks from baseline. RESULTS: Bedaquiline reduced the median time to culture conversion, as compared with placebo, from 125 days to 83 days (hazard ratio in the bedaquiline group, 2.44; 95% confidence interval, 1.57 to 3.80; P<0.001 by Cox regression analysis) and increased the rate of culture conversion at 24 weeks (79% vs. 58%, P = 0.008) and at 120 weeks (62% vs. 44%, P = 0.04). On the basis of World Health Organization outcome definitions for multidrug-resistant tuberculosis, cure rates at 120 weeks were 58% in the bedaquiline group and 32% in the placebo group (P = 0.003). The overall incidence of adverse events was similar in the two groups. There were 10 deaths in the bedaquiline group and 2 in the placebo group, with no causal pattern evident. CONCLUSIONS: The addition of bedaquiline to a preferred background regimen for 24 weeks resulted in faster culture conversion and significantly more culture conversions at 120 weeks, as compared with placebo. There were more deaths in the bedaquiline group than in the placebo group. en_US
dc.language.iso eng
dc.publisher Massachusetts Medical Society
dc.relation.ispartofseries New England Journal of Medicine
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Adolescent en_US
dc.subject Adult en_US
dc.subject Female en_US
dc.subject Humans en_US
dc.subject Male en_US
dc.subject Young Adult en_US
dc.subject Mycobacterium tuberculosis en_US
dc.subject Sputum en_US
dc.subject Middle Aged en_US
dc.subject Drug Therapy, Combination en_US
dc.subject pyrazinamide en_US
dc.subject Tuberculosis, Multidrug-Resistant en_US
dc.subject human en_US
dc.subject adult en_US
dc.subject aged en_US
dc.subject female en_US
dc.subject male en_US
dc.subject incidence en_US
dc.subject priority journal en_US
dc.subject controlled study en_US
dc.subject major clinical study en_US
dc.subject article en_US
dc.subject ethambutol en_US
dc.subject drug efficacy en_US
dc.subject headache en_US
dc.subject disease severity en_US
dc.subject kanamycin en_US
dc.subject placebo en_US
dc.subject Drug Administration Schedule en_US
dc.subject Antitubercular Agents en_US
dc.subject multicenter study en_US
dc.subject minimum inhibitory concentration en_US
dc.subject quinolone derivative en_US
dc.subject isoniazid en_US
dc.subject multidrug resistant tuberculosis en_US
dc.subject rifampicin en_US
dc.subject drug dose reduction en_US
dc.subject drug safety en_US
dc.subject drug withdrawal en_US
dc.subject phase 2 clinical trial en_US
dc.subject randomized controlled trial en_US
dc.subject sputum culture en_US
dc.subject drug sensitivity en_US
dc.subject arthralgia en_US
dc.subject cause of death en_US
dc.subject ethionamide en_US
dc.subject antibacterial activity en_US
dc.subject nausea en_US
dc.subject vomiting en_US
dc.subject treatment duration en_US
dc.subject hemoptysis en_US
dc.subject double blind procedure en_US
dc.subject unspecified side effect en_US
dc.subject aminoglycoside en_US
dc.subject bedaquiline en_US
dc.subject cycloserine en_US
dc.subject protionamide en_US
dc.subject hyperuricemia en_US
dc.subject Diarylquinolines en_US
dc.subject ofloxacin en_US
dc.subject antimycobacterial activity en_US
dc.subject Intention to Treat Analysis en_US
dc.subject sputum culture conversion en_US
dc.subject terizidone en_US
dc.title Multidrug-resistant tuberculosis and culture conversion with bedaquiline en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1056/NEJMoa1313865
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00
dc.relation.issn 1533-4406


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