Status:
RECRUITING
Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Lead Sponsor:
Thomas Benfield
Conditions:
Gram-negative Bacteremia
Urinary Tract Infection Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 neg...
Detailed Description
Introduction: Prolonged use of antibiotics is closely related to antibiotic-associated infections, anti-microbial resistance and adverse drug events. The optimal duration of antibiotic treatment for G...
Eligibility Criteria
Inclusion
- Age \>18 years
- Blood culture positive for Gram-negative bacteria
- Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)
- Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture
- Temperature \<37.8°C at randomization
- Clinically stabile at randomization (systolic blood pressure \> 90 mm Hg, heart rate \<100 beats/min., respiratory rate \<24/minute, peripheral oxygen saturation \> 90 %)
- Oral and written informed consent
Exclusion
- Antibiotic treatment (\>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days of inclusion
- Gram-negative bacteremia within 30 days of blood culture
- Immunosuppression (Untreated HIV-infection, Neutropenia (absolute neutrophil count \< 1.0 x 109/l), Untreated terminal cancer, Receiving immunosuppressive agents (ATC-code L04A), Corticosteroid treatment (≥20 mg/day prednisone or the equivalent for \>14 days) within the last 30 days, Chemotherapy within the last 30 days, Immunosuppressed after solid organ transplantation, Asplenia)
- Polymicrobial growth in blood culture
- Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp
- Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter á demeure)
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04291768
Start Date
March 11 2020
End Date
October 1 2026
Last Update
February 8 2023
Active Locations (13)
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1
University Hospital of Aalborg
Aalborg, Denmark, 9000
2
University Hospital of Aarhus
Aarhus, Denmark, 8200
3
Rigshospitalet
Copenhagen, Denmark, 2100
4
Bispebjerg Hospital
Copenhagen, Denmark, 2400