Afficher la notice abrégée

Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial

dc.rights.licenseopenen_US
dc.contributor.authorMAITRE, Thomas
dc.contributor.authorBONNET, Maryline
dc.contributor.authorCALMY, Alexandra
dc.contributor.authorRABERAHONA, Mihaja
dc.contributor.authorRAKOTOARIVELO, Rivonirina Andry
dc.contributor.authorRAKOTOSAMIMANANA, Niaina
dc.contributor.authorAMBROSIONI, Juan
dc.contributor.authorMIRO, Jose M.
dc.contributor.authorDEBEAUDRAP, Pierre
dc.contributor.authorMUZOORA, Conrad
dc.contributor.authorDAVIS, Angharad
dc.contributor.authorMEINTJES, Graeme
dc.contributor.authorWASSERMAN, Sean
dc.contributor.authorWILKINSON, Robert
dc.contributor.authorEHOLIE, Serge
dc.contributor.authorNOGBOU, Frederic Ello
dc.contributor.authorCALVO-CORTES, Maria-Camilla
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorCHAZALLON, Corine
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMACHAULT, Vanessa
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorANGLARET, Xavier
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
dc.date.accessioned2022-12-16T12:49:37Z
dc.date.available2022-12-16T12:49:37Z
dc.date.issued2022-11-08
dc.identifier.issn1745-6215 (Electronic) 1745-6215 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/171546
dc.description.abstractEnBACKGROUND: Tuberculous meningitis (TBM) is the most lethal and disabling form of tuberculosis (TB), particularly in sub-Saharan Africa. Current anti-TB treatment is poorly effective since TBM mortality reaches 40% in HIV-negative patients and up to 70% in HIV-co-infected patients. To reduce TBM-induced morbidity and mortality, the INTENSE-TBM trial evaluates two interventions in both HIV-infected and uninfected patients: an anti-TB treatment intensification using oral high-dose rifampicin (35 mg/kg daily) and linezolid (1200 mg daily and then 600 mg daily) during the first 8 weeks of the anti-TB treatment and the use of adjunctive aspirin (200 mg daily). METHODS: This is a randomized controlled, phase III, multicenter, 2 × 2 factorial plan superiority trial. The trial has four arms, combining the two experimental treatments (intensified TBM regimen and aspirin) with the two reference treatments (WHO standard TB treatment and placebo), and is open-label for anti-TB treatment and double-blind placebo-controlled for aspirin treatment. This trial is conducted in adults or adolescents of age ≥15 years with TBM defined as "definite," "probable," or "possible" using Tuberculosis Meningitis International Research Consortium criteria, in four African countries: Ivory Coast, Madagascar, Uganda, and South Africa. The primary outcome is all-cause death between inclusion and week 40. DISCUSSION: The INTENSE-TBM trial represents a key opportunity to enhance TBM treatment with widely available existing drugs notably in high-incidence settings of both TB and HIV. The trial design is pragmatic and the results will permit early and effective applications in TBM patient care, in both HIV and TB high-incidence countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04145258. Registered on October 30, 2019.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enRandomized controlled trial
dc.subject.enTuberculous meningitis
dc.subject.enAspirin
dc.subject.enLinezolid
dc.subject.enHIV High-dose rifampicin
dc.title.enIntensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13063-022-06772-1en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed36348453en_US
bordeaux.journalTrialsen_US
bordeaux.page928en_US
bordeaux.volume23en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03903474
hal.version1
hal.date.transferred2022-12-16T12:49:41Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Trials&rft.date=2022-11-08&rft.volume=23&rft.issue=1&rft.spage=928&rft.epage=928&rft.eissn=1745-6215%20(Electronic)%201745-6215%20(Linking)&rft.issn=1745-6215%20(Electronic)%201745-6215%20(Linking)&rft.au=MAITRE,%20Thomas&BONNET,%20Maryline&CALMY,%20Alexandra&RABERAHONA,%20Mihaja&RAKOTOARIVELO,%20Rivonirina%20Andry&rft.genre=article


Fichier(s) constituant ce document

Thumbnail
Nom:
BPH_Trials_2022_Maitre.pdf
Taille:
967.7Ko
Format:
PDF
Voir/Ouvrir
Thumbnail
Nom:
license_rdf
Taille:
914octets
Format:
application/rdf+xml
Voir/Ouvrir

Ce document figure dans la(les) collection(s) suivante(s)

Afficher la notice abrégée