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Lookup NU author(s): Professor Ruth Plummer
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 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.
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
Volume: 30
Issue: 1
Pages: 92-99
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
Data Access Statement: Requests for access to de-identified patient data can be made by researchers to the chief investigators, and data will be shared subject to any constraints. Requests for access should be accompanied by a proposal describing the aims and scope of the research, details of the data requested, and data analysis plan. Proposals will be considered by the Trial Management Group, co-investigators, and Sponsor who will make a decision regarding data access. A data-sharing agreement will be signed between the researchers, principal investigators, and Sponsor.
PubMed id: 37517522
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