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dc.contributor.authorTweed, C. D.
dc.contributor.authorWills, G. H.
dc.contributor.authorCrook, A. M.
dc.contributor.authorAmukoye, E.
dc.contributor.authorBalanag, V.
dc.contributor.authorBan, A. Y.L.
dc.contributor.authorBateson, A. L.C.
dc.contributor.authorBetteridge, M. C.
dc.contributor.authorBrumskine, W.
dc.contributor.authorCaoili, J.
dc.contributor.authorChaisson, R. E.
dc.contributor.authorCevik, M.
dc.contributor.authorConradie, F.
dc.contributor.authorDawson, R.
dc.contributor.authordel Parigi, A.
dc.contributor.authorDiacon, A.
dc.contributor.authorEveritt, D. E.
dc.contributor.authorFabiane, S.M.
dc.contributor.authorHunt, R.
dc.contributor.authorIsmail, A. I.
dc.contributor.authorLalloo, U.
dc.contributor.authorLombard, L.
dc.contributor.authorLouw, C.
dc.contributor.authorMalahleha, M.
dc.contributor.authorMcHugh, T. D.
dc.contributor.authorMendel, C. M.
dc.contributor.authorMhimbira, F.
dc.contributor.authorMoodliar, R. N.
dc.contributor.authorNduba, V.
dc.contributor.authorNunn, A. J.
dc.contributor.authorSabi, I.
dc.contributor.authorSebe, M. A.
dc.contributor.authorSelepe, R. A. P.
dc.contributor.authorStaples, S.
dc.contributor.authorSwindells, S.
dc.contributor.authorvan Niekerk, C. H.
dc.contributor.authorVariava, E.
dc.contributor.authorSpigelman, M.
dc.contributor.authorGillespie, S. H.
dc.date.accessioned2021-04-06T13:30:07Z
dc.date.available2021-04-06T13:30:07Z
dc.date.issued2021-04-01
dc.identifier.citationTweed , C D , Wills , G H , Crook , A M , Amukoye , E , Balanag , V , Ban , A Y L , Bateson , A L C , Betteridge , M C , Brumskine , W , Caoili , J , Chaisson , R E , Cevik , M , Conradie , F , Dawson , R , del Parigi , A , Diacon , A , Everitt , D E , Fabiane , S M , Hunt , R , Ismail , A I , Lalloo , U , Lombard , L , Louw , C , Malahleha , M , McHugh , T D , Mendel , C M , Mhimbira , F , Moodliar , R N , Nduba , V , Nunn , A J , Sabi , I , Sebe , M A , Selepe , R A P , Staples , S , Swindells , S , van Niekerk , C H , Variava , E , Spigelman , M & Gillespie , S H 2021 , ' A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB ' , International Journal of Tuberculosis and Lung Disease , vol. 25 , no. 4 , pp. 305-314 . https://doi.org/10.5588/ijtld.20.0513en
dc.identifier.issn1027-3719
dc.identifier.otherPURE: 273672846
dc.identifier.otherPURE UUID: a7167a10-20d6-44a2-a155-8bdcab4c84d6
dc.identifier.otherJisc: dce60838673f473f8a2e3b73eabd97c2
dc.identifier.otherORCID: /0000-0001-6537-7712/work/92019896
dc.identifier.otherORCID: /0000-0003-1133-3874/work/92020209
dc.identifier.otherScopus: 85103500407
dc.identifier.otherWOS: 000633227300007
dc.identifier.urihttp://hdl.handle.net/10023/21773
dc.descriptionSTAND was sponsored by TB Alliance with support from the UK Department for International Development, UK Department of Health (London, UK), Bill and Melinda Gates Foundation (Seattle, WA, USA), US Agency for International Development (Washington DC, USA), Directorate General for International Cooperation of the Netherlands (Amsterdam, The Netherlands), Irish Aid (Dublin, Ireland), Australia Department of Foreign Affairs and Trade (Canberra ACT, Australia) and the Federal Ministry for Education and Research of Germany (Berlin, Germany) through KfW (Kreditanstalt fur Wiederaufbau) and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH; Bethesda, MD, USA) under Award Numbers UM1 AI068634 and UM1 AI068636. AMC and AJN are supported by Medical Research Council Grant: MC_UU_12023/27 Tuberculosis Treatment Trials.en
dc.description.abstractBACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed. METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed. RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa200MZ, 4Pa200MZ, 4Pa100MZ and controls. There was a 6.6% (95% CI –2.2% to 15.4%) difference per protocol and 9.9% (95%CI –4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa200MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died. CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.
dc.format.extent10
dc.language.isoeng
dc.relation.ispartofInternational Journal of Tuberculosis and Lung Diseaseen
dc.rightsCopyright 2021 The Union. This article is Open Access under the terms of the Creative Commons CC BY licence.en
dc.subjectPulmonary and Respiratory Medicineen
dc.subjectInfectious Diseasesen
dc.subjectQR Microbiologyen
dc.subjectRM Therapeutics. Pharmacologyen
dc.subjectNDASen
dc.subject.lccQRen
dc.subject.lccRMen
dc.titleA partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TBen
dc.typeJournal articleen
dc.contributor.sponsorEuropean and Developing Countriesen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Infection and Global Health Divisionen
dc.contributor.institutionUniversity of St Andrews. Sir James Mackenzie Institute for Early Diagnosisen
dc.contributor.institutionUniversity of St Andrews. Centre for Biophotonicsen
dc.contributor.institutionUniversity of St Andrews. Biomedical Sciences Research Complexen
dc.contributor.institutionUniversity of St Andrews. Global Health Implementation Groupen
dc.contributor.institutionUniversity of St Andrews. Gillespie Groupen
dc.identifier.doihttps://doi.org/10.5588/ijtld.20.0513
dc.description.statusPeer revieweden
dc.identifier.grantnumberRIA2017S-2012en


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