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

Phase 1

• Conditions: ncomplicated bacteremia caused by E. faecalis or E. faecium.; MedDRA version: 20.1Level: PTClassification code: 10060945Term: Bacterial infection Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-508456-18-00
• Lead Sponsor: Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia., Negative control blood cultures performed between days 2-3 of treatment after the start of active treatment., Disappearance of fever (> 37.8ºC) in the first 72 hours., Signed informed consent

Exclusion Criteria

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 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, as well as infections that require prolonged treatment, such as joint and bone infections., Existence of a secondary focus, different from the initial focus or presence of metastatic focus of infection., 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of a 7-day antibiotic treatment regimen compared to a 14-day regimen in the treatment of uncomplicated enterococcal bacteremia, in terms of efficacy.;Secondary Objective: To evaluate the clinical response, length of hospital stay, relapse rate and presence of infective endocarditis during the first 90 days., To describe the efficacy of early oral sequential treatment., To evaluate the frequency of diarrhea due to C. difficile., To determine which microbiological factors influence the clinical course and the risk of relapse., To evaluate the safety related to both arms through the communication and evaluation of adverse events that occurred from the signing of the informed consent until 90 days after the administration of the study drugs., To establish and test the definition of uncomplicated enterococcal bacteremia;Primary end point(s): Clinical success at TOC in the ITTP.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP).;Secondary end point(s):Survival in OCD and follow-up visit.;Secondary end point(s):Length of hospital stay;Secondary end point(s):Duration of IV and total therapy in CEP;Secondary end point(s):Infection with C. difficile.;Secondary end point(s):Adverse events and severity;Secondary end point(s):Secondary infections;Secondary end point(s):Change in SOFA score in OCD and follow-up visit.