Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Benfield
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Shortened antibiotic treatment
- Standard antibiotic treatment
Treatment groups
380 Participants
are divided into 2 treatment groupsSponsors and collaborators
Thomas Benfield
Lead sponsor
Hvidovre University Hospital
Sponsor institution
Source ClinicalTrials.gov