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

Phase 1

• Conditions: Gram-negative Bacteremia; MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1; MedDRA version: 20.0Level: HLTClassification code: 10046577Term: Urinary tract infections Class: 10021881; MedDRA version: 20.1Level: LLTClassification code: 10054227Term: Gram-negative bacteraemia Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2024-514900-16-00
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Last Update Posted: 21 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 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

Study & Design

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