Adjuvant Clopidogrel in Staphylococcus Aureus Bacteremia
Spain230 participantsStarted 2026-06
Plain-language summary
The CLOPI-SNAP study is a randomized, multicenter, open-label clinical trial embedded within the SNAP (NCT 05137119) research platform. It constitutes a sub-study added to the core protocol for patients suffering Staphylococcus aureus bacteremia (SAB).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
To be eligible, patients must meet the same criteria as those of the general SNAP platform, as well as the domain-specific criteria:
* Microbiological isolation: Presence of Staphylococcus aureus complex in at least one blood culture.
* Hospitalization status: The patient must be admitted to a participating hospital at the time of eligibility assessment.
* Time window: Eligibility assessment must be completed within 72 hours after collection of the initial blood culture.
Exclusion Criteria:
General Medical and Safety Factors:
* Allergies: Known hypersensitivity to thienopyridines (clopidogrel, prasugrel, ticlopidine).
* Clinical status: Inability to tolerate or take oral medications, and severe hepatic impairment (Child-Pugh Class C).
* Pregnancy: Pregnant or breastfeeding women.
High Risk of Bleeding or Hematologic Disorders:
* Active or recent bleeding: Significant bleeding or invasive procedures within the previous 7 days.
* Planned surgeries: Requirement for major surgical intervention within 10 days following study enrollment.
* Coagulation parameters: Platelet count \<50,000/mm³ or known coagulation disorders.
* Concomitant medications: Patients already receiving regular aspirin therapy, other P2Y12 inhibitors, or therapeutic-dose anticoagulants (prophylactic-dose heparin is permitted).
Specific Diagnoses and Clinical Criteria:
* Endocarditis: Confirmed diagnosis or clinical suspicion of bacterial endocarditis. Sources indicate that exclusio…
What they're measuring
1
Desirability of Outcome Ranking (DOOR)
Timeframe: At day 90 from day 0.
Trial details
NCT IDNCT07384702
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla