NCT07384702

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
49mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 27, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

bacteriemiaStaphylococcus aureusadjunctive treatmentPlatform trialClopidogrelDesirability of Outcome Ranking

Outcome Measures

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.

    At day 90 from day 0.

Secondary Outcomes (4)

  • Mortality

    At day 14 and day 28 from day of assignment of study drug (day 0)

  • Length of stay of inpatient hospitalisation

    At day 90 from day 0.

  • Microbiological treatment failure

    At day 14 and day 90 from day of assignment of study drug (day 0)

  • New foci of infection

    At day 14 and day 90 from day of assignment of study drug (day 0)

Other Outcomes (1)

  • Major bleeding

    At day 90 from day 0.

Study Arms (2)

Oral clopidogrel

EXPERIMENTAL

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

No antiplatelet treatment

OTHER

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
Oral clopidogrel

Different concurrent antibiotic options currently approved for SAB

No antiplatelet treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • Medical judgment: If the treating clinical team determines that participation in this domain is not in the patient's best interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital General Universitario de Alicante

Alicante, Spain

Location

H.U. Clinic

Barcelona, Spain

Location

H.U. Mutua Terrassa

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario Bellvitge

Barcelona, Spain

Location

Hospital Universitario de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

H.U. Reina Sofía

Córdoba, Spain

Location

Hospital Universitario San Cecilio

Granada, Spain

Location

H.U. Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital Universitario La paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

Hospital Virgen Macarena

Seville, 41008, Spain

Location

H.U. Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Virgen de Valme

Seville, Spain

Location

Hospital Universitario Marqués de Valdecilla

Valdecilla, Spain

Location

Hospital Universitario Álvaro Cunqueiro

Vigo, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (5)

  • 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.

    PMID: 39158898BACKGROUND
  • 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.

    PMID: 39934879BACKGROUND
  • 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.

    PMID: 40618922BACKGROUND
  • Walls G, McGrath L, Herdman MT, Campbell AJ, Cheng MP, Marks M, Oever JT, Sahng E, Yahav D, Tong SYC, Goodman AL, Lim AG, Bloomfield M; Staphylococcus aureus Network Adaptive Platform Trial 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. 2025 Sep 24:ciaf522. doi: 10.1093/cid/ciaf522. Online ahead of print.

    PMID: 40988120BACKGROUND
  • 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.

    PMID: 37921609BACKGROUND

Related Links

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jesús Rodriguez Baños, PhD

    Hospital Universitario Virgen Macarena

    STUDY CHAIR

Central Study Contacts

Clara Rosso-Fernández, PhD

CONTACT

Silvia Jiménez-Jorge, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized 1:1 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 (antibiotic treatment according to SNAP assignment).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations