NCT07253688招募中3 期
Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus (RIFA-SNAP)
Todd C. Lee MD MPH FIDSA1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2025年11月10日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
This is a sub-study of the S. aureus Network Adaptive Platform (SNAP) trial (NCT05137119) wherein we will evaluate whether not giving rifampin in patients with probable or definite prosthetic valve endocarditis due to S. aureus is non-inferior to giving rifampin.
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
- Single (Outcomes Assessor)
盲法说明
The trial analyst will also be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probable or definite prosthetic valve endocarditis involving the tricuspid, pulmonic, mitral and/or aortic valves by the 2023 Duke-ISCVID Criteria (including Cardiac PET evidence if applicable);
- •Patient or healthcare proxy provide informed consent.
排除标准
- •Death deemed imminent and inevitable within days or patient will be receiving palliative care and has prognosis < 90 days according to the treating team;
- •Patient requires intensive care but has a do not resuscitate order precluding transfer;
- •Polymicrobial bacteremia (not including skin commensals or other recognized contaminant);
- •Organism tests as rifampin resistant;
- •History of hypersensitivity/anaphylaxis or severe adverse reaction to rifampin;
- •Category X or other important drug-drug interaction with rifampin which cannot be safely mitigated [with as-needed consultation from experts from pharmacy and/or internal medicine/geriatrics for potential deprescribing];
- •Child Pugh Class C cirrhosis;
- •Clinician deems rifampin to be mandatory;
- •Patient has already received >3 days of rifampin at time of screening or >10 days of total therapy
- •Pregnancy or breast feeding
- •Administrative exclusions:
- •No reliable means of outpatient contact (telephone/email/text);
- •Previously enrolled;
- •Prior S. aureus bacteremia within the preceding 180 days
研究组 & 干预措施
No rifampin
Experimental
These patients will not receive adjunctive rifampin.
干预措施: No rifampin (Other)
Adjunctive rifampin
Active Comparator
These patients will receive adjunctive rifampin as recommended in guidelines.
干预措施: Rifampin (Drug)
结局指标
主要结局
Treatment failure
时间窗: 180 days
A composite outcome of all cause mortality, unplanned cardiac surgery, new cardioembolic events, or relapse of bacteremia due to S. aureus.
次要结局
- Relapse of bacteremia(180 days)
- All-cause mortality(180 days)
- Unplanned cardiac surgery(180 days)
- New embolic events(180 days)
- Discontinuation of rifampin due to new drug-drug interaction(56 days)
- Serious adverse drug reaction due to rifampin(56 days)
- Discontinuation of rifampin due to an adverse drug reaction(56 days)
研究者
Todd C. Lee MD MPH FIDSA
Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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