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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2030-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Staphylococcus Aureus Endocarditis Prosthetic Valve Endocarditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The trial analyst will also be blinded.

Study Groups

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No rifampin

These patients will not receive adjunctive rifampin.

Group Type EXPERIMENTAL

No rifampin

Intervention Type OTHER

Subjects will be assigned to not receive adjunctive rifampin

Adjunctive rifampin

These patients will receive adjunctive rifampin as recommended in guidelines.

Group Type ACTIVE_COMPARATOR

Rifampin

Intervention Type DRUG

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

Interventions

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Rifampin

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

Intervention Type DRUG

No rifampin

Subjects will be assigned to not receive adjunctive rifampin

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No