ClinicalTrials.gg
Not yet recruitingNCT07384702CLOPI-SNAPUpdated Feb 5, 2026

Adjuvant Clopidogrel in Staphylococcus Aureus Bacteremia

A Phase 2 interventional study of Clopidogrel and No antiplatelet treatment in Bacteremia Due to Staphylococcus Aureus, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Not yet recruiting at 20 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Bacteremia Due to Staphylococcus Aureus

Keywords

  • bacteriemia
  • Staphylococcus aureus
  • adjunctive treatment
  • Platform trial
  • Clopidogrel
  • Desirability of Outcome Ranking
03

In context

Staphylococcal Infections

303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.

This study's planned enrollment of 230 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

General Medical and Safety Factors:

  • Allergies: Known to thienopyridines (clopidogrel, prasugrel, ticlopidine).
  • Clinical status: Inability to tolerate or take oral medications, and severe hepatic impairment ( 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: 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • 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

  • Other
    No antiplatelet treatment

    Patients receive different concurrent antibiotic options currently approved for SAB

    Drug: No antiplatelet treatment

Interventions

  • 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)

    Also known as: antiplatelet arm

  • DrugNo antiplatelet treatment

    Different concurrent antibiotic options currently approved for SAB

06

What researchers measure

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.

07

Study locations

20 sites
08

References and documents

Publications

  • Campbell AJ, Anpalagan K, Best EJ, Britton PN, Gwee A, Hatcher J, Manley BJ, Marsh J, Webb RH, Davis JS, Mahar RK, McGlothlin A, McMullan B, Meyer M, Mora J, Murthy S, Nourse C, Papenburg J, Schwartz KL, Scheuerman O, Snelling T, Strunk T, Stark M, Voss L, Tong SYC, Bowen AC; Staphylococcus aureus Network Adaptive Platform Paediatric and Youth (SNAP-PY) working groupSNAP Global Trial Steering Committee. Whole-of-Life Inclusion in Bayesian Adaptive Platform Clinical Trials. JAMA Pediatr. 2024 Oct 1;178(10):1066-1071. doi: 10.1001/jamapediatrics.2024.2697. PubMed 39158898 ↗
  • Mahar RK, McGlothlin A, Dymock M, Barina L, Bonten M, Bowen A, Cheng MP, Daneman N, Goodman AL, Lee TC, Lewis RJ, Lumley T, McLean ARD, McQuilten Z, Mora J, Paterson DL, Price DJ, Roberts J, Snelling T, Tverring J, Webb SA, Yahav D, Davis JS, Tong SYC, Marsh JA; SNAP Global Trial Steering Committee. Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial. Trials. 2025 Feb 11;26(1):49. doi: 10.1186/s13063-024-08684-8. PubMed 39934879 ↗
  • Boyles T, Bowen AC, Chomba R, Nel J, Davis JS, Tong SYC. Inclusion of a low- and middle-income country site in the Staphylococcus aureus Network Adaptive Platform trial: experiences from Johannesburg. Clin Microbiol Infect. 2025 Dec;31(12):1948-1950. doi: 10.1016/j.cmi.2025.06.032. Epub 2025 Jul 4. No abstract available. PubMed 40618922 ↗
  • Walls G, McGrath L, Herdman MT, Campbell AJ, Cheng MP, Marks M, Ten Oever J, Sahng E, Yahav D, Tong SYC, Goodman AL, Lim AG, Bloomfield M; Staphylococcus aureus Network Adaptive Platform Early Oral Switch Domain Specific Working Group. Patient-reported Perceptions, Experiences, and Preferences Around Intravenous and Oral Antibiotics for the Treatment of Staphylococcus aureus Bacteremia: A Descriptive Qualitative Study. Clin Infect Dis. 2026 Apr 30;82(4):e635-e642. doi: 10.1093/cid/ciaf522. PubMed 40988120 ↗
  • de Kretser D, Mora J, Bloomfield M, Campbell A, Cheng MP, Guy S, Hensgens M, Kalimuddin S, Lee TC, Legg A, Mahar RK, Marks M, Marsh J, McGlothin A, Morpeth SC, Sud A, Ten Oever J, Yahav D, Bonten M, Bowen AC, Daneman N, van Hal SJ, Heriot GS, Lewis RJ, Lye DC, McQuilten Z, Paterson DL, Owen Robinson J, Roberts JA, Scarborough M, Webb SA, Whiteway L, Tong SYC, Davis JS, Walls G, Goodman AL; SNAP Early Oral Switch Domain-Specific Working Group and SNAP Global Trial Steering Committee; SNAP Trial Group. Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol. Clin Infect Dis. 2024 Oct 15;79(4):871-887. doi: 10.1093/cid/ciad666. PubMed 37921609 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384702
Collaborators
University of Melbourne
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
Feb 5, 2026

Study contacts

Clara Rosso-Fernández, PhD
Contact
claram.rosso.sspa@juntadeandalucia.es
+34955012144
Silvia Jiménez-Jorge, PhD
Contact
silviajimenezjorge@gmail.com
+34955013114
Jesús Rodriguez Baños, PhD
study chair · Hospital Universitario Virgen Macarena

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Clopidogrel

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