Recruiting
Phase 3

Rifampin

Sponsor:

Todd C. Lee MD MPH FIDSA

Code:

NCT07253688

Conditions

Staphylococcus Aureus Endocarditis

Prosthetic Valve Endocarditis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rifampin

No rifampin

Study Details

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.

Conditions

Staphylococcus Aureus Endocarditis

Prosthetic Valve Endocarditis

Study ID

NCT07253688

Start date

Nov 10, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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);
2. Patient or healthcare proxy provide informed consent.

Exclusion Criteria:

1. Death deemed imminent and inevitable within days or patient will be receiving palliative care and has prognosis < 90 days according to the treating team;
2. Patient requires intensive care but has a do not resuscitate order precluding transfer;
3. Polymicrobial bacteremia (not including skin commensals or other recognized contaminant);
4. Organism tests as rifampin resistant;
5. History of hypersensitivity/anaphylaxis or severe adverse reaction to rifampin;
6. Category X or other important drug-drug interaction with rifampin which cannot be safely mitigated \[with as-needed consultation from experts from pharmacy and/or internal medicine/geriatrics for potential deprescribing\];
7. Child Pugh Class C cirrhosis;
8. Clinician deems rifampin to be mandatory;
9. Patient has already received >3 days of rifampin at time of screening or >10 days of total therapy
10. Pregnancy or breast feeding

Administrative exclusions:

1. No reliable means of outpatient contact (telephone/email/text);
2. Previously enrolled;
3. Prior S. aureus bacteremia within the preceding 180 days

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: No rifampin

These patients will not receive adjunctive rifampin.

active comparator: Adjunctive rifampin

These patients will receive adjunctive rifampin as recommended in guidelines.

Interventions

Rifampin

Patients will receive rifampin 900mg a day in 2-3 divided doses

No rifampin

Subjects will be assigned to not receive adjunctive rifampin

Primary outcome measure

  • Treatment failure [ Time Frame: 180 days ]

Central Contacts and Locations

Locations

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

Recruiting

Montreal, Quebec, Canada, H4A4S1

Contacts

Principal Investigator:

Todd C Lee, MD MPH FIDSA

More Information

Sponsor

Todd C. Lee MD MPH FIDSA

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • S. aureus bacteremia
  • Prosthetic valve endocarditis
  • Rifampin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Todd C. Lee MD MPH FIDSA on 2025-12-10.