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Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection

dc.rights.licenseopenen_US
dc.contributor.authorBERNARD, Louis
dc.contributor.authorARVIEUX, Cedric
dc.contributor.authorBRUNSCHWEILER, Benoit
dc.contributor.authorTOUCHAIS, Sophie
dc.contributor.authorANSART, Severine
dc.contributor.authorBRU, Jean-Pierre
dc.contributor.authorOZIOL, Eric
dc.contributor.authorBOERI, Cyril
dc.contributor.authorGRAS, Guillaume
dc.contributor.authorDRUON, Jerome
dc.contributor.authorROSSET, Philippe
dc.contributor.authorSENNEVILLE, Eric
dc.contributor.authorBENTAYEB, Houcine
dc.contributor.authorBOUHOUR, Damien
dc.contributor.authorLE MOAL, Gwenael
dc.contributor.authorMICHON, Jocelyn
dc.contributor.authorAUMAITRE, Hugues
dc.contributor.authorFORESTIER, Emmanuel
dc.contributor.authorLAFFOSSE, Jean-Michel
dc.contributor.authorBEGUE, Thierry
dc.contributor.authorCHIROUZE, Catherine
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDAUCHY, Frederic-Antoine
dc.contributor.authorDEVAUD, Edouard
dc.contributor.authorMARTHA, Benoit
dc.contributor.authorBURGOT, Denis
dc.contributor.authorBOUTOILLE, David
dc.contributor.authorSTINDEL, Eric
dc.contributor.authorDINH, Aurelien
dc.contributor.authorBEMER, Pascale
dc.contributor.authorGIRAUDEAU, Bruno
dc.contributor.authorISSARTEL, Bertrand
dc.contributor.authorCAILLE, Agnes
dc.date.accessioned2021-07-05T09:05:19Z
dc.date.available2021-07-05T09:05:19Z
dc.date.issued2021-05-27
dc.identifier.issn0028-4793en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/94965
dc.description.abstractEnBACKGROUND: The management of prosthetic joint infection usually consists of a combination of surgery and antimicrobial therapy. The appropriate duration of antimicrobial therapy for this indication remains unclear. METHODS: We performed an open-label, randomized, controlled, noninferiority trial to compare 6 weeks with 12 weeks of antibiotic therapy in patients with microbiologically confirmed prosthetic joint infection that had been managed with an appropriate surgical procedure. The primary outcome was persistent infection (defined as the persistence or recurrence of infection with the initial causative bacteria, with an antibiotic susceptibility pattern that was phenotypically indistinguishable from that at enrollment) within 2 years after the completion of antibiotic therapy. Noninferiority of 6 weeks of therapy to 12 weeks of therapy would be shown if the upper boundary of the 95% confidence interval for the absolute between-group difference (the value in the 6-week group minus the value in the 12-week group) in the percentage of patients with persistent infection within 2 years was not greater than 10 percentage points. RESULTS: A total of 410 patients from 28 French centers were randomly assigned to receive antibiotic therapy for 6 weeks (205 patients) or for 12 weeks (205 patients). Six patients who withdrew consent were not included in the analysis. In the main analysis, 20 patients who died during follow-up were excluded, and missing outcomes for 6 patients who were lost to follow-up were considered to be persistent infection. Persistent infection occurred in 35 of 193 patients (18.1%) in the 6-week group and in 18 of 191 patients (9.4%) in the 12-week group (risk difference, 8.7 percentage points; 95% confidence interval, 1.8 to 15.6); thus, noninferiority was not shown. Noninferiority was also not shown in the per-protocol and sensitivity analyses. We found no evidence of between-group differences in the percentage of patients with treatment failure due to a new infection, probable treatment failure, or serious adverse events. CONCLUSIONS: Among patients with microbiologically confirmed prosthetic joint infections that were managed with standard surgical procedures, antibiotic therapy for 6 weeks was not shown to be noninferior to antibiotic therapy for 12 weeks and resulted in a higher percentage of patients with unfavorable outcomes. (Funded by Programme Hospitalier de Recherche Clinique, French Ministry of Health; DATIPO ClinicalTrials.gov number, NCT01816009.).
dc.language.isoENen_US
dc.title.enAntibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection
dc.typeArticle de revueen_US
dc.identifier.doi10.1056/NEJMoa2020198en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34042388en_US
bordeaux.journalThe New England Journal of Medicineen_US
bordeaux.page1991-2001en_US
bordeaux.volume384en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue21en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamMORPH3Eusen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDMinistère des Solidarités et de la Santéen_US
hal.identifierhal-03277927
hal.version1
hal.date.transferred2021-07-05T09:05:26Z
hal.exporttrue
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