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Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.

Study acronym: DOBLEI
StatusRecruiting
PhasePhase 4
Started2024-10-09
View on ClinicalTrials.gov ↗

Amendment history

2025-07-24
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-30→confirmed 2024-10-09
Study sites17→18
InterventionsControl regimen (Drug), Experimental regimen (Drug)→Ampicillin plus ceftriaxone in continuous infusion (Drug), Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the…
Secondary endpoints13 to 12 entries
Treatment switching Serious adverseAdverse events
Study description-15 characters
[...] alis infective endocarditis is as effective and safe as the traditionalstandard intermittent infusiontreatment. The continuous infusion modality of treatment is expected [...]
2024-08-27
Study Status, Study Design v1
Enrollment target200→284
2024-05-16
Original filing
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 treatment, usually administered in hospitalized patients.
Trial Details
NCT Number NCT06423898
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Spanish Clinical Research Network - SCReN
Conditions Endocarditis, Infective
Enrollment 284 participants
Start Date 2024-10-09
Primary Completion 2027-07-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-25