Health TrialsbyHealthPanel

Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia

ConditionsGram-negative BacteremiaUrinary Tract Infection Bacterial
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Shortened antibiotic treatment

    Other intervention

    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.

  • Standard antibiotic treatment

    Other intervention

    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.

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

90-day survival without clinical or microbiological failure to treatment

90-day survival without clinical or microbiological failure to treatment as defined: 1. All-cause mortality from day of randomization and until day 90 2. Microbiological failure: Recurrent bacteremia due to the same microorganism as verified by sequence analysis occurring from day of randomization and until day 90 3. Clinical failure: Re-initiation of therapy against Gram-negative bacteremia for more than 48 hours due to clinical worsening suspected to be due to the initial infecting organism and for which there is no alternate diagnosis/pathogen suspected from the day of randomization and until day 90 1. Distant complications of initial infection, defined by growth of the same bacteria as in the initial bacteremia (e.g. endocarditis, meningitis) 2. Local suppurative complication that was not present at infection onset (e.g. renal abscess in pyelonephritis)

Time frame
90 days

Secondary outcomes

1

Mortality

Number of deaths by any cause

Time frame
14, 30 and 90 days
2

Total duration of antibiotic treatment

Days that the participant receives antibiotic treatment for Gram-negative bacteremia, adding intravenous and oral therapy

Time frame
90 days
3

Type of antibiotic treatment

Antibiotic treatment for Gram-negative bacteremia given by antibiogram

Time frame
90 days
4

Duration of antibiotic treatment

Duration of antibiotic treatment for Gram-negative bacteremia given by antibiogram

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Benfield

Lead sponsor

Hvidovre University Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now