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Phase 3Recruiting
View on ClinicalTrials.gov

Comparing No rifampin with Rifampin for staphylococcus aureus endocarditis

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

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

Condition: Staphylococcus Aureus EndocarditisSponsor: Todd C. Lee MD MPH FIDSATarget enrollment: 330
  • Phase 3
  • 2 groups
  • One site, in Montreal
  • Recruiting
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital), Montreal, Quebec

Interventions

  • Medication

    Rifampin

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

  • Other intervention

    No rifampin

    Subjects will be assigned to not receive adjunctive rifampin

Canadian Sites (1)

1 of 1 recruiting

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

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for16 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.

Exclusion

  • History of hypersensitivity/anaphylaxis or severe adverse reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → to rifampin;
  • 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;
  • 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or \>10 days of total therapy
  • Administrative exclusions:
  • No reliable means of outpatient contact (telephone/email/text);
  • Previously enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →;
  • Prior S. aureus bacteremia within the preceding 180 days
  • Pregnancy or breast feeding
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives No rifampin.

Registry label: A: No rifampin

Group B, the comparison group, receives Rifampin.

Registry label: B: Adjunctive rifampin

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 330 people.

The study is currently expected to finish around July 2030.

The main measurement is taken over: 180 days.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Treatment failure — measured over 180 days.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07253688 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About RifampinDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About No rifampinOther

Subjects will be assigned to not receive adjunctive rifampin

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 180 days.

The study as a whole is currently expected to finish around 2030-07.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 330 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.