Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH): a randomized non-inferiority trial.
Date
2023-07-28ICR Author
Author
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
EASI-SWITCH Investigators,
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Antibiotic
Febrile neutropenia
Neutropenic sepsis
Oral
Randomized controlled trial
Treatment
Language
eng
Date accepted
2023-07-22
License start date
2023-07-28
Citation
Clinical Microbiology and Infection, 2023, pp. S1198-743X(23)00349-X -
Publisher
ELSEVIER SCI LTD