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 groups

Locations

13
University Hospital of Aalborg9000, Aalborg Denmark
University Hospital of Aarhus8200, Aarhus Denmark
Bispebjerg Hospital2400, Copenhagen Denmark
Rigshospitalet2100, Copenhagen Denmark

Sponsors and collaborators

Thomas Benfield

Lead sponsor

Hvidovre University Hospital

Sponsor institution