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

ConditionsStaphylococcus Aureus EndocarditisProsthetic Valve Endocarditis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTodd C. Lee MD MPH FIDSA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rifampin

    Drug

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

  • No rifampin

    Other intervention

    Subjects will be assigned to not receive adjunctive rifampin

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: No rifampinExperimental treatment 1 intervention
Group B: Adjunctive rifampinActive comparator 1 intervention

Trial outcomes

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.

Time frame
180 days

Secondary outcomes

1

All-cause mortality

Death due to any cause

Time frame
180 days
2

Unplanned cardiac surgery

The need for cardiac surgery which was not planned or scheduled at the time of randomization.

Time frame
180 days
3

New embolic events

A new symptomatic cardio-embolic event occurring after randomization.

Time frame
180 days
4

Relapse of bacteremia

A new S. aureus bacteremia with the same susceptibility pattern (except for quinolones or rifampin in those who are exposed) which develops after sterilization of the initial blood cultures

Time frame
180 days

Other outcomes

1

Development of rifampin resistant S. aureus

Any clinically relevant isolate of S. aureus which demonstrates resistance to rifampin.

Time frame
180 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Todd C. Lee MD MPH FIDSA

Lead sponsor

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

Sponsor institution

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

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

University of Melbourne

Collaborator

The Peter Doherty Institute for Infection and Immunity

Collaborator

Source ClinicalTrials.gov
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