Comparison of the effect of shortened versus standard antibiotic treatment in patients infected with Gram negative bacteria with a urinary tract source of infection

Short course antibiotic treatment of Gram-negative bacteremia: A multicenter, randomized, non-blinded, non-inferiority interventional study - GNB5

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003282-17-DK

Enrollment

380

Registered

2019-12-05

Start date

2020-02-11

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-negative bacteremia MedDRA version: 20.1 Level: LLT Classification code 10054228 Term: Gram-negative bacteremia System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Ampicillin Other descriptive name: AMPICILLIN TRIHYDRATE Concentration unit: g gram(s) Concentration type: range Concentration number: 1-2 Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion 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 ==65 years) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: • • • Antibiotic treatment (>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days • Gram-negative bacteremia within 30 days of blood culture • Immunosuppression (Untreated HIV-infection, neutropenia (absolute neutrophil count = 20 mg/day prednisone or the equivalent for >14 days) within the last 30 days, chemotherapy within the last 30 days, immunosuppressive agents (ATC-code L04A), 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 a demure) • Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to assess efficacy and safety of shortened antibiotic duration (5 days) in treatment of Gram-negative bacteremia in hospitalized immunocompetent adults.;Secondary Objective: To reduce the consumption of antibiotics and thereby potentially decrease the risk of adverse events, obtain better patient adherence, reduce antimicrobial resistance and health care costs.;Primary end point(s): 90-day survival without clinical or microbiological failure to treatment or relapse in patients receiving a shortened or a standard course of antibiotic treatment;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Main Objective: The aim of this study is to assess efficacy and safety of shortened antibiotic duration (5 days) in treatment of Gram-negative bacteremia in hospitalized immunocompetent adults.;Secondary Objective: To reduce the consumption of antibiotics and thereby potentially decrease the risk of adverse events, obtain better patient adherence, reduce antimicrobial resistance and health care costs.;Primary end point(s): 90-day survival without clinical or microbiological failure to treatment or relapse in patients receiving a shortened or a standard course of antibiotic treatment;Timepoint(s) of evaluation of this end point: 90 days

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Secondary

Measure	Time frame
Secondary end point(s): • All-cause mortality at days 14, 28 and 90 • Total duration of antibiotic treatment • Type of antibiotic treatment • Total length of hospital stay • Hospital re-admission • Severe adverse events grade >3 • Acute kidney injury – defined according to RIFLE criteria as increased creatinine level x 1.5 from baseline or estimated glomerular filtration rate (eGFR) decrease >25% or urine output of <0.5 ml/kg/h for 6 hours. R • Clostridum difficile infection • Multidrug-resistance organism defined as identification of resistant bacteria in clinical specimen obtained only from a clinical infection. ;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Secondary end point(s): • All-cause mortality at days 14, 28 and 90 • Total duration of antibiotic treatment • Type of antibiotic treatment • Total length of hospital stay • Hospital re-admission • Severe adverse events grade >3 • Acute kidney injury – defined according to RIFLE criteria as increased creatinine level x 1.5 from baseline or estimated glomerular filtration rate (eGFR) decrease >25% or urine output of <0.5 ml/kg/h for 6 hours. R • Clostridum difficile infection • Multidrug-resistance organism defined as identification of resistant bacteria in clinical specimen obtained only from a clinical infection. ;Timepoint(s) of evaluation of this end point: 90 days

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Countries

Denmark

Contacts

Public ContactThomas Benfield

Thomas Benfield

thomas.lars.benfield@regionh.dk+4520544094

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026