PMID- 37517522
OWN - NLM
STAT- MEDLINE
DCOM- 20240101
LR  - 20240101
IS  - 1469-0691 (Electronic)
IS  - 1198-743X (Linking)
VI  - 30
IP  - 1
DP  - 2024 Jan
TI  - Early switch to oral antibiotic therapy in patients with low-risk neutropenic 
      sepsis (EASI-SWITCH): a randomized non-inferiority trial.
PG  - 92-99
LID - S1198-743X(23)00349-X [pii]
LID - 10.1016/j.cmi.2023.07.021 [doi]
AB  - 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, -infinity% 
      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, -infinity% 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.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Coyle, Vicky
AU  - Coyle V
AD  - Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, 
      Belfast, UK.
FAU - Forde, Caroline
AU  - Forde C
AD  - Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, 
      Belfast, UK.
FAU - McAuley, Danny F
AU  - McAuley DF
AD  - The Wellcome Wolfson Institute for Experimental Medicine, Queens University 
      Belfast, Belfast, UK.
FAU - Wilson, Richard H
AU  - Wilson RH
AD  - Translational Research Centre, University of Glasgow, Glasgow, UK.
FAU - Clarke, Mike
AU  - Clarke M
AD  - Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK; 
      Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, 
      Belfast, UK.
FAU - Plummer, Ruth
AU  - Plummer R
AD  - Translational and Clinical Research Institute, Newcastle University, Newcastle, 
      UK.
FAU - Grayson, Margaret
AU  - Grayson M
AD  - Northern Ireland Cancer Research Consumer Forum, Belfast, UK.
FAU - McDowell, Cliona
AU  - McDowell C
AD  - Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, 
      Belfast, UK.
FAU - Agus, Ashley
AU  - Agus A
AD  - Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, 
      Belfast, UK.
FAU - Doran, Annmarie
AU  - Doran A
AD  - Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, 
      Belfast, UK.
FAU - Thomas, Anne L
AU  - Thomas AL
AD  - Leicester Cancer Research Centre, University of Leicester, Leicester, UK.
FAU - Barnes, Rosemary A
AU  - Barnes RA
AD  - Cardiff University School of Medicine, Centre for Trials Research, Cardiff, UK.
FAU - Adams, Richard
AU  - Adams R
AD  - Cardiff University School of Medicine, Centre for Trials Research, Cardiff, UK; 
      Velindre NHS Trust, Department of medical oncology, Cardiff, UK.
FAU - Chau, Ian
AU  - Chau I
AD  - The Royal Marsden NHS Foundation Trust, Gastrointestinal and lymphoma unit, 
      London, UK.
FAU - Storey, Dawn
AU  - Storey D
AD  - The Beatson West of Scotland Cancer Centre, Department of medical oncology, 
      Glasgow, UK.
FAU - McMullan, Ronan
AU  - McMullan R
AD  - The Wellcome Wolfson Institute for Experimental Medicine, Queens University 
      Belfast, Belfast, UK. Electronic address: r.mcmullan@qub.ac.uk.
CN  - EASI-SWITCH Investigators
LA  - eng
PT  - Equivalence Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230728
PL  - England
TA  - Clin Microbiol Infect
JT  - Clinical microbiology and infection : the official publication of the European 
      Society of Clinical Microbiology and Infectious Diseases
JID - 9516420
RN  - 0 (Anti-Bacterial Agents)
RN  - 5E8K9I0O4U (Ciprofloxacin)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Anti-Bacterial Agents
MH  - Ciprofloxacin/therapeutic use
MH  - *Sepsis/drug therapy/chemically induced
MH  - *Neutropenia/complications
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Antibiotic
OT  - Febrile neutropenia
OT  - Neutropenic sepsis
OT  - Oral
OT  - Randomized controlled trial
OT  - Treatment
EDAT- 2023/07/31 00:41
MHDA- 2024/01/02 11:43
CRDT- 2023/07/30 19:14
PHST- 2023/04/25 00:00 [received]
PHST- 2023/07/19 00:00 [revised]
PHST- 2023/07/22 00:00 [accepted]
PHST- 2024/01/02 11:43 [medline]
PHST- 2023/07/31 00:41 [pubmed]
PHST- 2023/07/30 19:14 [entrez]
AID - S1198-743X(23)00349-X [pii]
AID - 10.1016/j.cmi.2023.07.021 [doi]
PST - ppublish
SO  - Clin Microbiol Infect. 2024 Jan;30(1):92-99. doi: 10.1016/j.cmi.2023.07.021. Epub 
      2023 Jul 28.