PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia.
Details
State: Public
Version: Final published version
Serval ID
serval:BIB_720959F3BFF9
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia.
Journal
BMJ open
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
13/07/2017
Peer-reviewed
Oui
Volume
7
Number
7
Pages
e017996
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: epublish
Publication Status: epublish
Abstract
Antibiotic overuse drives antibiotic resistance. The optimal duration of antibiotic therapy for Gram-negative bacteraemia (GNB), a common community and hospital-associated infection, remains unknown and unstudied via randomised controlled trials (RCTs).
This investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values. The randomisation will occur in equal proportions (1:1:1) on day 5 (±1) of efficacious antibiotic therapy as determined by antibiogram; patients, their physicians and study investigators will be blind to treatment duration allocation until the day of antibiotic discontinuation. Immunosuppressed patients and those with GNB due to complicated infections (endocarditis, osteomyelitis, etc) and/or non-fermenting bacilli ( <i>Acinetobacter</i> spp, <i>Burkholderia</i> spp, <i>Pseudomonas</i> spp) <i>Brucella</i> spp, <i>Fusobacterium</i> spp or polymicrobial growth with Gram-positive organisms will be ineligible. The primary outcome is incidence of clinical failure at day 30; secondary outcomes include clinical failure, all-cause mortality and incidence of <i>Clostridiumdifficile</i> infection in the 90-day study period. An interim safety analysis will be performed after the first 150 patients have been followed for ≤30 days. Given a chosen margin of 10%, the required sample size to determine non-inferiority is roughly 500 patients. Analyses will be performed on both intention-to-treat and per-protocol populations.
Ethics approval was obtained from the cantonal ethics committees of all three participating sites. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
This trial is registered at www.clinicaltrials.gov (NCT03101072; pre-results).
This investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values. The randomisation will occur in equal proportions (1:1:1) on day 5 (±1) of efficacious antibiotic therapy as determined by antibiogram; patients, their physicians and study investigators will be blind to treatment duration allocation until the day of antibiotic discontinuation. Immunosuppressed patients and those with GNB due to complicated infections (endocarditis, osteomyelitis, etc) and/or non-fermenting bacilli ( <i>Acinetobacter</i> spp, <i>Burkholderia</i> spp, <i>Pseudomonas</i> spp) <i>Brucella</i> spp, <i>Fusobacterium</i> spp or polymicrobial growth with Gram-positive organisms will be ineligible. The primary outcome is incidence of clinical failure at day 30; secondary outcomes include clinical failure, all-cause mortality and incidence of <i>Clostridiumdifficile</i> infection in the 90-day study period. An interim safety analysis will be performed after the first 150 patients have been followed for ≤30 days. Given a chosen margin of 10%, the required sample size to determine non-inferiority is roughly 500 patients. Analyses will be performed on both intention-to-treat and per-protocol populations.
Ethics approval was obtained from the cantonal ethics committees of all three participating sites. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
This trial is registered at www.clinicaltrials.gov (NCT03101072; pre-results).
Keywords
Adolescent, Adult, Aged, Anti-Bacterial Agents/therapeutic use, Bacteremia/drug therapy, C-Reactive Protein/analysis, Cross Infection/drug therapy, Drug Resistance, Microbial, Female, Gram-Negative Bacteria/drug effects, Gram-Negative Bacterial Infections/drug therapy, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Point-of-Care Systems, Prescription Drug Overuse/prevention & control, Regression Analysis, Switzerland, Young Adult, Antibiotic Therapy, Bacteraemia, Duration, Gram-negative, Point-of-care Randomization
Pubmed
Web of science
Open Access
Yes
Create date
28/08/2017 9:34
Last modification date
20/08/2019 15:30
Usage data
