Phase 2 Platform Randomized, Multicentre and Open Trial on the Efficacy and Safety of Clopidogrel as Adjuvant Drug in Staphylococcus Aureus Bacteraemia (CLOPI-SNAP)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 230
- 试验地点
- 20
- 主要终点
- Desirability of Outcome Ranking (DOOR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Clopidogrel (Drug)
No antiplatelet treatment
Patients receive different concurrent antibiotic options currently approved for SAB
干预措施: No antiplatelet treatment (Drug)
结局指标
主要结局
Desirability of Outcome Ranking (DOOR)
时间窗: 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.
次要结局
- 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))