Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
Trial Parameters
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 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
Inclusion Criteria: * 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 Criteria: * 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), Corticoster