Adjuvant Clopidogrel in Staphylococcus Aureus Bacteremia (CLOPI-SNAP)

February 3, 2026 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Phase 2 Platform Randomized, Multicentre and Open Trial on the Efficacy and Safety of Clopidogrel as Adjuvant Drug in Staphylococcus Aureus Bacteraemia (CLOPI-SNAP)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The CLOPI-SNAP study evaluates whether the administration of clopidogrel as adjunctive therapy improves clinical outcomes while maintaining an acceptable safety profile in hospitalized patients with Staphylococcus aureus bacteremia (SAB).

To be eligible for the SNAP platform (NCT 05137119), patients must meet at least two criteria: isolation of the Staphylococcus aureus complex from ≥1 blood culture and admission to a participating hospital at the time of eligibility assessment. SNAP is designed to concurrently evaluate multiple therapeutic strategies. Patients are randomly assigned to different concurrent treatment options that are currently considered acceptable in routine clinical practice; thus, standard-of-care therapy consists of approved antibiotics for the treatment of Staphylococcus aureus infection.

Specifically, patients participating in CLOPI-SNAP-adult patients with SAB enrolled in the SNAP platform-are randomized in a 1:1 ratio to receive either oral clopidogrel for 5 days, administered as a 300-mg loading dose on Day 1 followed by 75 mg once daily on subsequent days, or no antiplatelet therapy. The primary endpoint is the Desirability of Outcome Ranking (DOOR) assessed at Day 90, a hierarchical composite outcome integrating survival, clinical failure, infectious complications, and the occurrence of serious adverse events. The limited 5-day duration of clopidogrel administration is intended to focus its potential therapeutic benefit on the early phase of infection, characterized by high bacterial burden and systemic inflammation, while minimizing the risk of bleeding associated with prolonged antiplatelet exposure.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 exclusion of endocarditis is justified because the potential benefit of clopidogrel is expected during early phases of high bacterial burden, whereas bleeding risk increases with prolonged treatment or established deep-seated infections.
  • Medical judgment: If the treating clinical team determines that participation in this domain is not in the patient's best interest.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral clopidogrel
Oral 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) added to different concurrent antibiotic options currently approved for SAB
Drug: Clopidogrel
Oral 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)
Other Names:
  • antiplatelet arm
Other: No antiplatelet treatment
Patients receive different concurrent antibiotic options currently approved for SAB
Drug: No antiplatelet treatment
Different concurrent antibiotic options currently approved for SAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desirability of Outcome Ranking (DOOR)
Time Frame: At day 90 from day 0.
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.
At day 90 from day 0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: At day 14 and day 28 from day of assignment of study drug (day 0)
Dead of any cause
At day 14 and day 28 from day of assignment of study drug (day 0)
Length of stay of inpatient hospitalisation
Time Frame: At day 90 from day 0.
Length of hospital stay in days from patient enrollment into the study to the time of hospital discharge or death
At day 90 from day 0.
Microbiological treatment failure
Time Frame: At day 14 and day 90 from day of assignment of study drug (day 0)
Defined as a positive S. aureus culture from a sterile site (deep tissue or abscess).
At day 14 and day 90 from day of assignment of study drug (day 0)
New foci of infection
Time Frame: At day 14 and day 90 from day of assignment of study drug (day 0)
Diagnosis of new infection foci, based on clinical, radiological, microbiological, or pathological findings.
At day 14 and day 90 from day of assignment of study drug (day 0)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding
Time Frame: At day 90 from day 0.
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.
At day 90 from day 0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

University of Melbourne

Investigators

  • Study Chair: Jesús Rodriguez Baños, PhD, Hospital Universitario Virgen Macarena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOPI-SNAP
  • 2023-503582-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information will be made available upon completion of the study. During the study period and data preparation phase, the information will be under the custody and responsibility of the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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