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

Coyle, Vicky, Forde, Caroline, McAuley, Danny F., Wilson, Richard H., Clarke, Mike, Plummer, Ruth, Grayson, Margaret, McDowell, Cliona, Agus, Ashley, Doran, Annmarie, Thomas, Anne L., Barnes, Rosemary A., Adams, Richard ORCID: https://orcid.org/0000-0003-3915-7243, Chau, Ian, Storey, Dawn and McMullan, Ronan 2024. Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH): a randomized non-inferiority trial. Clinical Microbiology and Infection 30 (1) , pp. 92-99. 10.1016/j.cmi.2023.07.021

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Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Centre for Trials Research (CNTRR)
Publisher:	Elsevier
ISSN:	1198-743X
Date of First Compliant Deposit:	30 August 2023
Date of Acceptance:	22 July 2023
Last Modified:	06 Feb 2024 16:22
URI:	https://orca.cardiff.ac.uk/id/eprint/162026

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