RecruitingPhase 4NCT04291768

Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study


Sponsor

Thomas Benfield

Enrollment

380 participants

Start Date

Mar 11, 2020

Study Type

INTERVENTIONAL

Conditions

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%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Shortened antibiotic treatment and Standard antibiotic treatment for people with gram-negative bacteremia and urinary tract infection bacterial. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERShortened 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.

OTHERStandard 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

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NCT04291768


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