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

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dc.authorid0000-0001-8022-7325
dc.authorid0000-0001-8930-741X
dc.contributor.authorOmrani, Ali S.
dc.contributor.authorAbujarir, Sulieman H.
dc.contributor.authorBen Abid, Fatma
dc.contributor.authorShaar, Shahd H.
dc.contributor.authorYılmaz, Mesut
dc.contributor.authorShaukat, Adila
dc.contributor.authorAlsamawi, Mussad S.
dc.contributor.authorElgara, Mohamed S.
dc.contributor.authorAlghazzawi, Mohamed Islam
dc.contributor.authorShunnar, Khaled M.
dc.contributor.authorZaqout, Ahmed
dc.contributor.authorAldeeb, Yasser M.
dc.contributor.authorAlfouzan, Wadha
dc.contributor.authorAlmaslamani, Muna A.
dc.contributor.authorAlqahtani, Manaf
dc.contributor.authorAlshaikh, Faisal
dc.contributor.authorNazish, Mohammad
dc.contributor.authorAlmerdasi, Noura
dc.contributor.authorBangri, Simin
dc.contributor.authorÇakmak, Rümeysa
dc.contributor.authorKurt, Celali
dc.contributor.authorAltunçekiç Yıldırım, Arzu
dc.contributor.authorTükenmez Tigen, Elif
dc.contributor.authorErtürk Şengel, Buket
dc.contributor.authorBalkan, İlker İnanç
dc.contributor.authorÇağlar, Bilge
dc.contributor.authorAbufaied, Mohamed M.
dc.contributor.authorEledrisi, Mohsen S.
dc.contributor.authorAbusriwil, Hatem
dc.contributor.authorElmaghboul, Emad
dc.date.accessioned2024-06-11T05:49:35Z
dc.date.available2024-06-11T05:49:35Z
dc.date.issued2024
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Ana Bilim Dalı
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü, Tıbbi Biyokimya Ana Bilim Dalı
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.description.sponsorshipQatar National Research Fund (QNRF)en_US
dc.identifier.citationOmrani, A. S., Abujarir, S. H., Ben Abid, F., Shaar, S. H., Yılmaz, M., Shaukat, A. ... Elmaghboul, E. (2024). Switch to oral antibiotics in gram-negative bacteraemia: a randomized, open-label, clinical trial. Clinical Microbiology and Infection, 30(4), 492-498. http://dx.doi.org/10.1016/j.cmi.2023.10.014
dc.identifier.doi10.1016/j.cmi.2023.10.014
dc.identifier.endpage498
dc.identifier.issn1198-743X
dc.identifier.issn1469-0691
dc.identifier.issue4
dc.identifier.pmid37858867
dc.identifier.scopus2-s2.0-85175715590
dc.identifier.scopusqualityQ1
dc.identifier.startpage492
dc.identifier.urihttp://dx.doi.org/10.1016/j.cmi.2023.10.014
dc.identifier.urihttps://hdl.handle.net/20.500.12511/12610
dc.identifier.volume30
dc.identifier.wos001225874200001en_US
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorYılmaz, Mesut
dc.institutionauthorÇakmak, Rümeysa
dc.language.isoen
dc.relation.ecinfo:eu-repo/grantAgreement/MRC-01-19-254
dc.relation.ispartofClinical Microbiology and Infectionen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
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

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