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Switch to oral antibiotics in Gram-negative bacteraemia: a randomized, open-label, clinical trial

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dc.contributor.authorERTÜRK ŞENGEL, BUKET
dc.contributor.authorsOmrani A. S., Abujarir S. H., Ben Abid F., Shaar S. H., Yilmaz M., Shaukat A., Alsamawi M. S., Elgara M. S., Alghazzawi M. I., Shunnar K. M., et al.
dc.date.accessioned2023-12-18T06:13:25Z
dc.date.available2023-12-18T06:13:25Z
dc.date.issued2023-01-01
dc.description.abstractObjectives: To evaluate the safety and efficacy of switching from intravenous (IV) to oral antimicrobial therapy in patients with Enterobacterales bacteraemia, after completion of 3–5 days of microbiologically active IV therapy. Methods: A multicentre, open-label, randomized trial of adults with monomicrobial Enterobacterales bacteraemia caused by a strain susceptible to ≥1 oral beta-lactam, quinolone, or trimethoprim/sulfamethoxazole. Inclusion criteria included completion of 3–5 days of microbiologically active IV therapy, being afebrile and haemodynamically stable for ≥48 hours, and absence of an uncontrolled source of infection. Pregnancy, endocarditis, and neurological infections were exclusion criteria. Randomization, stratified by urinary source of bacteraemia, was to continue IV (IV Group) or to switch to oral therapy (Oral Group). Agents and duration of therapy were determined by the treating physicians. The primary endpoint was treatment failure, defined as death, need for additional antimicrobial therapy, microbiological relapse, or infection-related re-admission within 90 days. Non-inferiority threshold was set at 10% in the 95% CI for the difference in the proportion with treatment failure between the Oral and IV Groups in the modified intention-to-treat population. The protocol was registered at ClinicalTrials.gov (NCT04146922). Results: In the modified intention-to-treat population, treatment failure occurred in 21 of 82 (25.6%) in the IV Group, and 18 of 83 (21.7%) in the Oral Group (risk difference –3.7%, 95% CI –16.6% to 9.2%). The proportions of subjects with any adverse events (AE), serious AE, or AE leading to treatment discontinuation were comparable. Discussion: In patients with Enterobacterales bacteraemia, oral switch, after initial IV antimicrobial therapy, clinical stability, and source control, is non-inferior to continuing IV therapy.
dc.identifier.citationOmrani A. S., Abujarir S. H., Ben Abid F., Shaar S. H., Yilmaz M., Shaukat A., Alsamawi M. S., Elgara M. S., Alghazzawi M. I., Shunnar K. M., et al., "Switch to oral antibiotics in Gram-negative bacteraemia: a randomized, open-label, clinical trial", Clinical Microbiology and Infection, 2023
dc.identifier.doi10.1016/j.cmi.2023.10.014
dc.identifier.issn1198-743X
dc.identifier.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85175715590&origin=inward
dc.identifier.urihttps://hdl.handle.net/11424/295672
dc.language.isoeng
dc.relation.ispartofClinical Microbiology and Infection
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectTıp
dc.subjectMikrobiyoloji ve Klinik Mikrobiyoloji
dc.subjectYaşam Bilimleri
dc.subjectSağlık Bilimleri
dc.subjectTemel Tıp Bilimleri
dc.subjectTemel Bilimler
dc.subjectMedicine
dc.subjectMicrobiology and Clinical Microbiology
dc.subjectLife Sciences
dc.subjectHealth Sciences
dc.subjectFundamental Medical Sciences
dc.subjectNatural Sciences
dc.subjectYaşam Bilimleri (LIFE)
dc.subjectİmmünoloji
dc.subjectMikrobiyoloji
dc.subjectBULAŞICI HASTALIKLAR
dc.subjectMİKROBİYOLOJİ
dc.subjectLife Sciences (LIFE)
dc.subjectIMMUNOLOGY
dc.subjectMICROBIOLOGY
dc.subjectINFECTIOUS DISEASES
dc.subjectMikrobiyoloji (tıbbi)
dc.subjectBulaşıcı hastalıklar
dc.subjectMicrobiology (medical)
dc.subjectInfectious Diseases
dc.subjectBacteraemia
dc.subjectEnterobacterales
dc.subjectGram negative
dc.subjectOral therapy
dc.subjectStep down
dc.subjectSwitch
dc.titleSwitch to oral antibiotics in Gram-negative bacteraemia: a randomized, open-label, clinical trial
dc.typearticle
dspace.entity.typePublication
local.avesis.id549bcf77-a3b1-47b8-9ea7-d3fa04681a2b
local.indexed.atPUBMED
local.indexed.atSCOPUS
relation.isAuthorOfPublication67d5b9df-08b7-4c37-b042-45ea89a4c23d
relation.isAuthorOfPublication.latestForDiscovery67d5b9df-08b7-4c37-b042-45ea89a4c23d

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