Clinical trial to evaluate the safety and efficacy of a 7-day versus 14-day treatment for enterococcal infections.

Phase 1

• Conditions: Adult patients with uncomplicated bacteremia caused by E. faecalis or E. faecium.; MedDRA version: 20.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003891-15-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

- Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia.
- Adequate early control of the focus of bacteremia within 72 hours in
the cases in which it is feasible and necessary
- Negative control blood cultures performed between days 2-3 of treatment
- Disappearance of fever (> 37.8ºC) in the first 72 hours.
- Signed 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 241
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

- Patients with limited life expectancy in whom only conservative clinical management had been decided.
- Hemodynamic instability on day 5-6.
- Patients wearing endovascular devices or heart valves
prosthetics.
- Outbreak of uncontrolled bacteremia adequately defined as abscess not
drained, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteremia, other
infections related to unremoved prostheses, prostatitis, and endocarditis
infectious.
- Existence of a secondary focus, different from the initial focus.
- Severe neutropenia (<500 cells / mm3) at the time of diagnosis of
bacteremia
- Pregnancy and lactation.

Study & Design

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