Switch to oral antibiotics in gram-negative bacteraemia: a randomized, open-label, clinical trial
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info:eu-repo/semantics/openAccessTarih
2024Yazar
Omrani, Ali S.Abujarir, Sulieman H.
Ben Abid, Fatma
Shaar, Shahd H.
Yılmaz, Mesut
Shaukat, Adila
Alsamawi, Mussad S.
Elgara, Mohamed S.
Alghazzawi, Mohamed Islam
Shunnar, Khaled M.
Zaqout, Ahmed
Aldeeb, Yasser M.
Alfouzan, Wadha
Almaslamani, Muna A.
Alqahtani, Manaf
Alshaikh, Faisal
Nazish, Mohammad
Almerdasi, Noura
Bangri, Simin
Çakmak, Rümeysa
Kurt, Celali
Altunçekiç Yıldırım, Arzu
Tükenmez Tigen, Elif
Ertürk Şengel, Buket
Balkan, İlker İnanç
Çağlar, Bilge
Abufaied, Mohamed M.
Eledrisi, Mohsen S.
Abusriwil, Hatem
Elmaghboul, Emad
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Omrani, 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.2023.10.014Özet
Objectives: 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.
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Clinical Microbiology and InfectionCilt
30Sayı
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