Recruiting NCT07253688
Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rifampin, No rifampin.
- Who it may be relevant to
- Registry conditions: Staphylococcus Aureus Endocarditis, Prosthetic Valve Endocarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus (RIFA-SNAP)
Overview
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.
Interventions
- Drug Rifampin
Patients will receive rifampin 900mg a day in 2-3 divided doses - Other No rifampin
Subjects will be assigned to not receive adjunctive rifampin
Primary outcome measures
- Treatment failure [Time frame: 180 days]
Secondary outcome measures (7)
- All-cause mortality [Time frame: 180 days]
- Unplanned cardiac surgery [Time frame: 180 days]
- New embolic events [Time frame: 180 days]
- Relapse of bacteremia [Time frame: 180 days]
- Discontinuation of rifampin due to new drug-drug interaction [Time frame: 56 days]
- Serious adverse drug reaction due to rifampin [Time frame: 56 days]
- Discontinuation of rifampin due to an adverse drug reaction [Time frame: 56 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) — Montreal
Publications
- 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 36408468
- McDonald 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, Sanctua PMID 37523190
Identifiers
NCT: NCT07253688 · 2025-10882