Clinical trial
Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Intermittent Infusion for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOBLEI)
Name
DOBLEI
Description
Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen, usually administered in hospitalized patients.
Trial arms
Trial start
2024-09-30
Estimated PCD
2027-07-31
Trial end
2028-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Experimental regimen
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
Arms:
Continuous intravenous antibiotic infusion
Control regimen
Intermittent intravenous antibiotic infusion during 42 days for Infective Endocarditis
Arms:
Intermittent intravenous antibiotic infusion
Size
200
Primary endpoint
Clinical failure
One year after the end of the treatment
Eligibility criteria
Inclusion Criteria:
* Adult patients
* Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
* Signed informed consent of patients
Exclusion Criteria:
* Allergy to penicillins or cephalosporins
* Pregnancy and lactation
* Polymicrobial infection including microorganisms different to E. faecalis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Randomized 1:1 to experimental group (continuous infusion arm) or control group (intermittent infusion arm)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-05-21
1 organization
2 products
2 indications
Product
Experimental regimenIndication
EndocarditisIndication
InfectiveProduct
Control regimen