Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus
RIFA-SNAP
1 other identifier
interventional
330
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2025
Longer than P75 for phase_3
1 active site
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
Study Start
First participant enrolled
November 10, 2025
CompletedFirst Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
December 10, 2025
December 1, 2025
4.1 years
November 19, 2025
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment failure
A composite outcome of all cause mortality, unplanned cardiac surgery, new cardioembolic events, or relapse of bacteremia due to S. aureus.
180 days
Secondary Outcomes (7)
All-cause mortality
180 days
Unplanned cardiac surgery
180 days
New embolic events
180 days
Relapse of bacteremia
180 days
Discontinuation of rifampin due to new drug-drug interaction
56 days
- +2 more secondary outcomes
Other Outcomes (1)
Development of rifampin resistant S. aureus
180 days
Study Arms (2)
No rifampin
EXPERIMENTALThese patients will not receive adjunctive rifampin.
Adjunctive rifampin
ACTIVE COMPARATORThese patients will receive adjunctive rifampin as recommended in guidelines.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- No reliable means of outpatient contact (telephone/email/text);
- Previously enrolled;
- Prior S. aureus bacteremia within the preceding 180 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, H4A4S1, Canada
Related Publications (2)
Ryder JH, Tong SYC, Gallagher JC, McDonald EG, Thevarajan I, Lee TC, Cortes-Penfield NW. Deconstructing the Dogma: Systematic Literature Review and Meta-analysis of Adjunctive Gentamicin and Rifampin in Staphylococcal Prosthetic Valve Endocarditis. Open Forum Infect Dis. 2022 Oct 31;9(11):ofac583. doi: 10.1093/ofid/ofac583. eCollection 2022 Nov.
PMID: 36408468BACKGROUNDMcDonald EG, Aggrey G, Aslan AT, Casias M, Cortes-Penfield N, Dong MQD, Egbert S, Footer B, Isler B, King M, Maximos M, Wuerz TC, Azim AA, Alza-Arcila J, Bai AD, Blyth M, Boyles T, Caceres J, Clark D, Davar K, Denholm JT, Forrest G, Ghanem B, Hagel S, Hanretty A, Hamilton F, Jent P, Kang M, Kludjian G, Lahey T, Lapin J, Lee R, Li T, Mehta D, Moore J, Mowrer C, Ouellet G, Reece R, Ryder JH, Sanctuaire A, Sanders JM, Stoner BJ, So JM, Tessier JF, Tirupathi R, Tong SYC, Wald-Dickler N, Yassin A, Yen C, Spellberg B, Lee TC. Guidelines for Diagnosis and Management of Infective Endocarditis in Adults: A WikiGuidelines Group Consensus Statement. JAMA Netw Open. 2023 Jul 3;6(7):e2326366. doi: 10.1001/jamanetworkopen.2023.26366.
PMID: 37523190BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The trial analyst will also be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
November 10, 2025
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
July 1, 2030
Last Updated
December 10, 2025
Record last verified: 2025-12