Status:
UNKNOWN
Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborating Sponsors:
Spanish Network for Research in Infectious Diseases
Spanish Clinical Research Network - SCReN
Conditions:
Enterococcal Bacteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 (DO...
Detailed Description
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. faeca...
Eligibility Criteria
Inclusion
- Adult patients (18 years of age or older) hospitalised with monomicrobial E. faecalis or E. faecium bacteremia.
- 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.
- The previous version allowed this inclusion criterion "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)", which is now removed because it is already an exclusion criterion.
Exclusion
- patients with polymicrobial bacteremia
- Patients with limited life expectancy in whom only conservative clinical management had been decided.
- Hemodynamic instability on day 5-6 after the start of active treatment.
- 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, as well as infections that require prolonged treatment, such as joint and bone infections.
- Existence of a secondary focus, different from the initial one, or presence of metastatic focus of infection.
- Severe neutropenia (\<500 cells / mm3) at the time of bacteremia diagnosis.
- Pregnancy and lactation.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT05394298
Start Date
July 11 2022
End Date
December 15 2024
Last Update
May 3 2023
Active Locations (22)
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1
COMPLEJO Universitario de La Coruña
A Coruña, A Coruña, Spain, 15006
2
Hospital Universitario Torrecárdenas
Almería, Almeria, Spain, 04009
3
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
4
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221