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Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH): a randomized non-inferiority trial

Lookup NU author(s): Professor Ruth Plummer

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2023 The Author(s)Objectives: To determine whether early switch to oral antibiotic treatment in adults with neutropenic sepsis at low risk of complications is non-inferior to switching later. Methods: This non-inferiority, parallel-group, randomized, open-label clinical trial enrolled UK adults hospitalized with neutropenic sepsis. Participants were randomly assigned to either switch to oral ciprofloxacin plus co-amoxiclav within 12–24 hours or to continue intravenous treatment for at least 48 hours. The primary outcome was a composite measure of treatment failure, 14 days after randomization. The non-inferiority margin was 15%. Results: There were 129 participants from 16 centres and 125 were assessed for the primary outcome. Of these, 113 patients completed protocolized treatment and comprised the per-protocol population. In total, 9 (14.1%) of 64 patients in the standard care arm met the primary end point, compared with 15 (24.6%) of 61 in the early switch arm, giving a risk difference of 10.5% (1-sided 95% CI, −∞% to 22%; p 0.14). In the per-protocol population, 8 (13.3%) of the 60 patients in the standard care arm met the primary end point, compared with 9 (17%) of 53 in the intervention arm giving a risk difference of 3.7% (one-sided 95% CI, −∞% to 14.8%; p 0.59). Duration of hospital stay was shorter in the intervention arm (median 2 [inter-quartile range (IQR) 2–3] vs. 3 days [IQR 2–4]; p 0.002). Discussion: Although non-inferiority of early oral switch was found in the per-protocol population, the intervention was not non-inferior in the intent-to-treat population.


Publication metadata

Author(s): Coyle V, Forde C, McAuley DF, Wilson RH, Clarke M, Plummer R, Grayson M, McDowell C, Agus A, Doran A, Thomas AL, Barnes RA, Adams R, Chau I, Storey D, McMullan R

Publication type: Article

Publication status: Published

Journal: Clinical Microbiology and Infection

Year: 2023

Pages: epub ahead of print

Online publication date: 28/07/2023

Acceptance date: 22/07/2023

Date deposited: 25/09/2023

ISSN (print): 1198-743X

ISSN (electronic): 1469-0691

Publisher: Elsevier B.V.

URL: https://doi.org/10.1016/j.cmi.2023.07.021

DOI: 10.1016/j.cmi.2023.07.021

PubMed id: 37517522


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Funding

Funder referenceFunder name
13/140/05
NIHR Health Technology Assessment Programme

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