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NCT05389904 · ClinicalTrials.gov registry record · NA

Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile

A NA study of C. Difficile, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
1
Study location

NCT05389904: Recruiting NA study of C. Difficile, sponsored by Brigham and Women's Hospital.

NCT05389904 is a NA study of C. Difficile that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05389904, a NA study of C. Difficile, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
1
Study location

Study Summary

Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.

Primary Outcome

Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle

Conditions Studied

Interventions

  • OTHER Arm 1: Routine care
  • OTHER Arm 2: Preemptive C. difficile infection prevention bundle

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2022-07-25
Est. Completion 2026-08
Phase NA
Brigham and Women's Hospital

937 total trials

What NCT05389904 shows while recruiting

NCT05389904 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 1 condition, with C. Difficile appearing as the primary indexed condition, and to 2 interventions - of which Arm 1: Routine care is the first listed.

NCT05389904 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05389904 about?

NCT05389904 is a clinical study titled "Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile". Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmissi...

What is the current status of trial NCT05389904?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-07-25. Estimated completion is 2026-08.

What conditions does trial NCT05389904 study?

This clinical trial studies the following conditions: C. Difficile.

What interventions are being tested in trial NCT05389904?

The interventions under investigation include: Arm 1: Routine care (OTHER), Arm 2: Preemptive C. difficile infection prevention bundle (OTHER).

Who is sponsoring clinical trial NCT05389904?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05389904 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for C. Difficile

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05389904's enrollment target sits among peer trials

300 330th of 2000 higher than 1,630 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05389904, the US trial registry maintained by the National Library of Medicine. NCT05389904 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.