Actively Recruiting
Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Led by Thomas Benfield · Updated on 2023-02-08
380
Participants Needed
13
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Blood culture positive for Gram-negative bacteria
- Evidence of urinary tract source of infection (positive urine culture or compatible clinical symptoms)
- Antibiotic treatment with activity against Gram-negative bacteria started within 12 hours of first blood culture
- Temperature below 37.8°C at randomization
- Clinically stable at randomization (systolic blood pressure >90 mm Hg, heart rate <100 beats/min, respiratory rate <24/min, peripheral oxygen saturation >90%)
- Oral and written informed consent
You will not qualify if you...
- Antibiotic treatment for more than 2 days with activity against Gram-negative bacteria within 14 days before inclusion
- Gram-negative bacteremia within 30 days prior to blood culture
- Immunosuppression including untreated HIV, neutropenia, untreated terminal cancer, immunosuppressive agents, corticosteroids ≥20 mg/day prednisone or equivalent for >14 days within last 30 days, chemotherapy within last 30 days, post-solid organ transplantation status, or asplenia
- Polymicrobial growth in blood culture
- Bacteremia caused by non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp
- Failure to remove infection source within 72 hours of first blood culture
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University Hospital of Aalborg
Aalborg, Denmark, 9000
Not Yet Recruiting
2
University Hospital of Aarhus
Aarhus, Denmark, 8200
Not Yet Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Not Yet Recruiting
4
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
5
Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
6
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
7
Herning Hospital
Herning, Denmark, 7400
Not Yet Recruiting
8
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Actively Recruiting
9
Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
10
Kolding Hospital
Kolding, Denmark, 6000
Not Yet Recruiting
11
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
12
Roskilde Hospital
Roskilde, Denmark, 4000
Not Yet Recruiting
13
Regionshospitalet Silkeborg
Silkeborg, Denmark, 8600
Not Yet Recruiting
Research Team
S
Sandra Tingsgård, MD
CONTACT
T
Thomas Benfield, MD DMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here