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RECRUITINGPhase 4INTERVENTIONAL

Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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%.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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), 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

Treatments Being Tested

OTHER

Shortened antibiotic treatment

Shortened antibiotic treatment of 5 days. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.

OTHER

Standard antibiotic treatment

Standard antibiotic treatment of minimum 7 days at the discretion of treating physician. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.

Locations (13)

University Hospital of Aalborg
Aalborg, Denmark
University Hospital of Aarhus
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Herlev Hospital
Herlev, Denmark
Herning Hospital
Herning, Denmark
Nordsjaellands Hospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Kolding Hospital
Kolding, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Regionshospitalet Silkeborg
Silkeborg, Denmark