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
|
Preview |
PDF
- Published Version
Available under License Creative Commons Attribution. Download (724kB) | Preview |
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: | Schools > Medicine Research Institutes & Centres > 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 |
Actions (repository staff only)
 |
Edit Item |
Dimensions
Dimensions