Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07253688

Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to Staphylococcus Aureus (RIFA-SNAP)

Led by Todd C. Lee MD MPH FIDSA · Updated on 2025-12-10

330

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

T

Todd C. Lee MD MPH FIDSA

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating treatment options for patients with probable or definite prosthetic valve endocarditis caused by Staphylococcus aureus. The study aims to determine whether not giving rifampin, an antibiotic, is no worse than giving rifampin alongside standard care. This is a Phase 3 randomized clinical trial led by Todd C. Lee MD MPH FIDSA. Participants will be randomly assigned to one of two groups: one will receive adjunctive rifampin at a dose of 900 mg per day divided into 2-3 doses, while the other group will not receive rifampin. The study will follow participants for outcomes related to treatment success or failure, including monitoring for adverse reactions and other complications. During the trial, participants will be monitored for treatment failure over 180 days, including deaths, unplanned cardiac surgery, new embolic events, and relapse of bacteremia. Additional assessments within 56 days will track discontinuation of rifampin due to drug interactions or adverse reactions. Participants will be followed closely to evaluate safety and effectiveness throughout the study period, which extends up to 180 days after treatment begins.

CONDITIONS

Brief Title

Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 provides informed consent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Death deemed imminent and inevitable within days or patient will be receiving palliative care with prognosis less than 90 days
  • Patient requires intensive care but has a do not resuscitate order precluding transfer
  • Polymicrobial bacteremia (excluding skin commensals or recognized contaminants)
  • Organism tests as rifampin resistant
  • History of hypersensitivity/anaphylaxis or severe adverse reaction to rifampin
  • Category X or important drug-drug interaction with rifampin that cannot be safely managed
  • Child Pugh Class C cirrhosis
  • Clinician deems rifampin mandatory
  • Patient has already received more than 3 days of rifampin at screening or more than 10 days of total therapy
  • Pregnancy or breastfeeding
  • No reliable means of outpatient contact (telephone/email/text)
  • Previously enrolled
  • Prior S. aureus bacteremia within the preceding 180 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 56 days

Participants receive either adjunctive rifampin or no rifampin as part of their treatment for prosthetic valve endocarditis.

Regular visits during treatment period as per clinical guidelines

Follow-up

Duration - Up to 180 days

Participants are monitored for treatment failure, mortality, and other health outcomes after treatment completion.

Scheduled follow-up visits over 6 months

Trial Site Locations

Total: 1 location

1

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, Canada, H4A4S1

Actively Recruiting

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Research Team

L

Lina Petrella

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Deconstructing the Dogma: Systematic Literature Review and Meta-analysis of Adjunctive Gentamicin and Rifampin in Staphylococcal Prosthetic Valve Endocarditis.

Jonathan H Ryder, Steven Y C Tong, Jason C Gallagher...

https://pubmed.ncbi.nlm.nih.gov/36408468

Guidelines for Diagnosis and Management of Infective Endocarditis in Adults: A WikiGuidelines Group Consensus Statement.

Emily G McDonald, Gloria Aggrey, Abdullah Tarik Aslan...

https://pubmed.ncbi.nlm.nih.gov/37523190