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RECRUITING
NCT04291768
PHASE4

Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

Sponsor: Thomas Benfield

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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