Adjuvant Clopidogrel in Staphylococcus Aureus Bacteremia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Active or recent bleeding: Significant bleeding or invasive procedures within the previous 7 days.
Trial design
Design model
Parallel
Treatments tested in this trial
Clopidogrel
DrugOral clopidogrel 75 mg pills; 300 mg from domain reveal (day 1 of treatment), followed by 75 mg daily until day 5 of treatment inclusive (4 additional calendar days)
No antiplatelet treatment
DrugDifferent concurrent antibiotic options currently approved for SAB
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Oral clopidogrelExperimental treatment 1 intervention
Group B: No antiplatelet treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Desirability of Outcome Ranking (DOOR)
Desirability of Outcome Ranking is an ordinal scale that classifies each patient's overall clinical outcome from 1 to 5, integrating survival, clinical response, and serious adverse events. DOOR 1 represents the most favorable outcome (alive with clinical cure or improvement and no serious adverse events); DOOR 2, clinical cure or improvement with serious adverse events; DOOR 3, alive with clinical failure and no serious adverse events; DOOR 4, clinical failure with serious adverse events; and DOOR 5, death, representing the least desirable outcome. Lower numerical values indicate more favorable overall clinical outcomes.
Time frame
At day 90 from day 0.Secondary outcomes
1
Mortality
Dead of any cause
Time frame
At day 14 and day 28 from day of assignment of study drug (day 0)2
Length of stay of inpatient hospitalisation
Length of hospital stay in days from patient enrollment into the study to the time of hospital discharge or death
Time frame
At day 90 from day 0.3
Microbiological treatment failure
Defined as a positive S. aureus culture from a sterile site (deep tissue or abscess).
Time frame
At day 14 and day 90 from day of assignment of study drug (day 0)4
New foci of infection
Diagnosis of new infection foci, based on clinical, radiological, microbiological, or pathological findings.
Time frame
At day 14 and day 90 from day of assignment of study drug (day 0)Other outcomes
1
Major bleeding
Defined as any bleeding that is fatal, occurs in a critical organ or area, causes a hemoglobin drop of ≥2 g/dL, or requires transfusion of ≥2 units of blood.
Time frame
At day 90 from day 0.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead sponsor
University of Melbourne
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: