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Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

NCT04291768 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2023-02-08

No results posted yet for this study

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%.

Conditions

  • Gram-negative Bacteremia
  • Urinary Tract Infection Bacterial

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.

Sponsors & Collaborators

  • Thomas Benfield

    lead OTHER

Principal Investigators

  • Sandra Tingsgård, MD · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291768 on ClinicalTrials.gov