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

被引:4
|
作者
Coyle, Vicky [1 ]
Forde, Caroline [1 ]
Mcauley, Danny F. [2 ]
Wilson, Richard H. [3 ]
Clarke, Mike [4 ,5 ]
Plummer, Ruth [6 ]
Grayson, Margaret [7 ]
Mcdowell, Cliona [5 ]
Agus, Ashley [5 ]
Doran, Annmarie [5 ]
Thomas, Anne L. [8 ]
Barnes, Rosemary A. [9 ]
Adams, Richard [9 ,10 ]
Chau, Ian [11 ]
Storey, Dawn [12 ]
McMullan, Ronan [2 ,13 ]
机构
[1] Queens Univ Belfast, Patrick G Johnston Ctr Canc Res, Belfast, North Ireland
[2] Queens Univ Belfast, Wellcome Wolfson Inst Expt Med, Belfast, North Ireland
[3] Univ Glasgow, Translat Res Ctr, Glasgow, Scotland
[4] Queens Univ Belfast, Northern Ireland Methodol Hub, Belfast, Antrim, North Ireland
[5] Belfast Hlth & Social Care Trust, Northern Ireland Clin Trials Unit, Belfast, North Ireland
[6] Newcastle Univ, Translat & Clin Res Inst, Newcastle, England
[7] Northern Ireland Canc Res Consumer Forum, Belfast, North Ireland
[8] Univ Leicester, Leicester Canc Res Ctr, Leicester, England
[9] Cardiff Univ, Sch Med, Ctr Trials Res, Cardiff, Wales
[10] Dept Med oncol, Velindre NHS Trust, Cardiff, Wales
[11] Royal Marsden NHS Fdn Trust, Gastrointestinal Lymphoma Unit, London, England
[12] Beatson West Scotland Canc Ctr, Med Oncol, Glasgow, Scotland
[13] Queens Univ Belfast, Wellcome Wolfson Inst Expt Med, 97 Lisburn Rd, Belfast BT9 7BL, North Ireland
关键词
Antibiotic; Febrile neutropenia; Neutropenic sepsis; Oral; Randomized controlled trial; Treatment; EMPIRIC THERAPY; CANCER; FEVER;
D O I
10.1016/j.cmi.2023.07.021
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
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 cip-rofloxacin 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 randomi-zation. 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. Vicky Coyle, Clin Microbiol Infect 2024;30:92 (c) 2023 The Author(s). Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
引用
收藏
页码:92 / 99
页数:8
相关论文
共 50 条
  • [1] Early switch to oral antibiotic therapy in patients with low-risk neutropenic sepsis (EASI-SWITCH trial)
    Coyle, V.
    Forde, C.
    Adams, R.
    Barnes, R.
    Chau, I.
    Clarke, M.
    Doran, A.
    Grayson, M.
    McAuley, D.
    McDowell, C.
    Phair, G.
    Plummer, R.
    Thomas, A.
    Wilson, R.
    McMullan, R.
    ANNALS OF ONCOLOGY, 2021, 32 : S1188 - S1188
  • [2] The EASI-SWITCH trial: Early switch to oral antibiotic therapy in patients with low risk neutropenic sepsis.
    Forde, Caroline
    McMullan, Ronan
    Clarke, Mike
    Wilson, Richard H.
    Plummer, Elizabeth R.
    Thomas, Anne L.
    Barnes, Rosemary A.
    Adams, Richard A.
    Chau, Ian
    Grayson, Margaret
    McDowell, Cliona
    Agus, Ashley
    Brown, Ewan
    Storey, Dawn Jane
    McAuley, Danny
    Coyle, Victoria
    JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (15)
  • [3] Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis: the EASI-SWITCH RCT
    Coyle, Vicky
    Forde, Caroline
    Adams, Richard
    Agus, Ashley
    Barnes, Rosemary
    Chau, Ian
    Clarke, Mike
    Doran, Annmarie
    Grayson, Margaret
    Mcauley, Danny
    Mcdowell, Cliona
    Phair, Glenn
    Plummer, Ruth
    Storey, Dawn
    Thomas, Anne
    Wilson, Richard
    Mcmullan, Ronan
    HEALTH TECHNOLOGY ASSESSMENT, 2024, 28 (14) : 1 - 101
  • [4] Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial
    Forde, Caroline
    McMullan, Ronan
    Clarke, Mike
    Wilson, Richard H.
    Plummer, Ruth
    Grayson, Margaret
    McDowell, Cliona
    Agus, Ashley
    Doran, Annmarie
    McAuley, Danny F.
    Thomas, Anne L.
    Barnes, Rosemary A.
    Adams, Richard
    Chau, Ian
    Coyle, Vicky
    TRIALS, 2020, 21 (01)
  • [5] Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial
    Caroline Forde
    Ronan McMullan
    Mike Clarke
    Richard H. Wilson
    Ruth Plummer
    Margaret Grayson
    Cliona McDowell
    Ashley Agus
    Annmarie Doran
    Danny F. McAuley
    Anne L. Thomas
    Rosemary A. Barnes
    Richard Adams
    Ian Chau
    Vicky Coyle
    Trials, 21
  • [6] Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial
    Achim J. Kaasch
    Gerd Fätkenheuer
    Reinhild Prinz-Langenohl
    Ursula Paulus
    Martin Hellmich
    Verena Weiß
    Norma Jung
    Siegbert Rieg
    Winfried V. Kern
    Harald Seifert
    Trials, 16
  • [7] Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial
    Kaasch, Achim J.
    Faetkenheuer, Gerd
    Prinz-Langenohl, Reinhild
    Paulus, Ursula
    Hellmich, Martin
    Weiss, Verena
    Jung, Norma
    Rieg, Siegbert
    Kern, Winfried V.
    Seifert, Harald
    TRIALS, 2015, 16
  • [8] Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
    Kaasch, Achim J.
    Rommerskirchen, Anna
    Hellmich, Martin
    Faetkenheuer, Gerd
    Prinz-Langenohl, Reinhild
    Rieg, Siegbert
    Kern, Winfried, V
    Seifert, Harald
    TRIALS, 2020, 21 (01)
  • [9] Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
    Achim J. Kaasch
    Anna Rommerskirchen
    Martin Hellmich
    Gerd Fätkenheuer
    Reinhild Prinz-Langenohl
    Siegbert Rieg
    Winfried V. Kern
    Harald Seifert
    Trials, 21
  • [10] Efficacy of Early Oral Switch with β-Lactams for Low-Risk Staphylococcus aureus Bacteremia
    Bupha-Intr, Olivia
    Blackmore, Tim
    Bloomfield, Max
    ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2020, 64 (07)