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Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Sponsor: Thomas Benfield
Summary
GNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic for patients hospitalized with a Gram negative bacteremia with a urinary tract source of infection (GNB). Five days after initiation of antimicrobial therapy for GNB, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. The primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.
Official title: Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2020-03-11
Completion Date
2026-10-01
Last Updated
2023-02-08
Healthy Volunteers
No
Interventions
Shortened antibiotic treatment
Shortened antibiotic treatment of 5 days. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.
Standard antibiotic treatment
Standard antibiotic treatment of minimum 7 days at the discretion of treating physician. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.
Locations (13)
University Hospital of Aalborg
Aalborg, Denmark
University Hospital of Aarhus
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Herlev Hospital
Herlev, Denmark
Herning Hospital
Herning, Denmark
Nordsjaellands Hospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Kolding Hospital
Kolding, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Regionshospitalet Silkeborg
Silkeborg, Denmark