Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia

• Status: Not yet recruiting
• Trial end date: 2024-11-15
• Target enrollment: 0
• Participant gender: All

Summary

Randomized clinical trial to determine the optimal duration of antibiotic treatment for E. Faecalis or E. faecium bacteraemia, following an innovative DOOR / RADAR (Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)) analysis methodology.

Phase IV clinical trial, open-labelled, randomized, pragmatic, multicenter study to demonstrate non-inferiority of a 7-day antibiotic regimen vs. 14 days in the treatment of bacteremia due to E. faecalis or E. faecium.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: Spanish Clinical Research Network - SCReN; Spanish Network for Research in Infectious Diseases
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• Adult patients (18 years of age or older) hospitalised with monomicrobial E. faecalis or E. faecium bacteremia.

• Early adequate control of the source of bacteremia within 72 hours in the cases in which it is feasible and necessary (urinary or biliary tract release; abscess drainage; catheter-removal, etc).

• Negative follow-up blood cultures performed between days 2 and 3 of active treatment.

• Disappearance of fever (>37.8ºC) within the first 72 hours.

• Signed informed consent.

Exclusion Criteria:

• Patients with limited life expectancy in whom only conservative clinical management had been decided.

• Hemodynamic instability on day 5-7.

• Patients wearing endovascular devices or prosthetic heart valves.

• Source of uncontrolled bacteremia adequately defined as undrained abscess, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteraemia, other infections related to non-removed prostheses, prostatitis, and infective endocarditis.

• Existence of a secondary focus, different from the initial one.

• Severe neutropenia (<500 cells / mm3) at the time of bacteremia diagnosis.

• Pregnancy and lactation.