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Clinical trial to evaluate the safety and efficacy of a 7-day versus 14-day treatment for enterococcal infections.
EU CTIS ID: 2023-508456-18-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.