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

Phase 1

• Conditions: Gram-negative bacteremia; MedDRA version: 20.1Level: LLTClassification code 10054228Term: Gram-negative bacteremiaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-003282-17-DK
• Lead Sponsor: Thomas Benfield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 380

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 (SBP = 90 mm Hg, HR = 100/min., RR = 24/min., SAT = 90%) at randomization
• Oral and written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

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• 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 < 1.0 x 109/l, untreated terminal cancer, corticosteroid treatment (>= 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • All-cause mortality at days 14, 28 and 90<br>• Total duration of antibiotic treatment<br>• Type of antibiotic treatment<br>• Total length of hospital stay<br>• Hospital re-admission<br>• Severe adverse events grade >3 <br>• 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<br>• Clostridum difficile infection<br>• 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