Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH) : a randomized non-inferiority trial
Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
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| Enthalten in: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - 30(2024), 1 vom: 28. Jan., Seite 92-99 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Coyle, Vicky [VerfasserIn] |
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| Links: |
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| Themen: |
5E8K9I0O4U |
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| Anmerkungen: |
Date Completed 01.01.2024 Date Revised 01.01.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cmi.2023.07.021 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360173837 |
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| 100 | 1 | |a Coyle, Vicky |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH) |b a randomized non-inferiority trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 01.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Equivalence Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antibiotic | |
| 650 | 4 | |a Febrile neutropenia | |
| 650 | 4 | |a Neutropenic sepsis | |
| 650 | 4 | |a Oral | |
| 650 | 4 | |a Randomized controlled trial | |
| 650 | 4 | |a Treatment | |
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| 700 | 1 | |a McAuley, Danny F |e verfasserin |4 aut | |
| 700 | 1 | |a Wilson, Richard H |e verfasserin |4 aut | |
| 700 | 1 | |a Clarke, Mike |e verfasserin |4 aut | |
| 700 | 1 | |a Plummer, Ruth |e verfasserin |4 aut | |
| 700 | 1 | |a Grayson, Margaret |e verfasserin |4 aut | |
| 700 | 1 | |a McDowell, Cliona |e verfasserin |4 aut | |
| 700 | 1 | |a Agus, Ashley |e verfasserin |4 aut | |
| 700 | 1 | |a Doran, Annmarie |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Anne L |e verfasserin |4 aut | |
| 700 | 1 | |a Barnes, Rosemary A |e verfasserin |4 aut | |
| 700 | 1 | |a Adams, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Chau, Ian |e verfasserin |4 aut | |
| 700 | 1 | |a Storey, Dawn |e verfasserin |4 aut | |
| 700 | 1 | |a McMullan, Ronan |e verfasserin |4 aut | |
| 700 | 0 | |a EASI-SWITCH Investigators |e verfasserin |4 aut | |
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