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NCT07221370 · ClinicalTrials.gov registry record · Phase 2
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
A Phase 2 study of Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection, sponsored by Riverside University Health System Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
- 1
- Study location
NCT07221370: Recruiting Phase 2 study of Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection, sponsored by Riverside University Health System Medical Center.
NCT07221370 is a Phase 2 study of Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection that is actively recruiting participants, run by Riverside University Health System Medical Center. The registered enrollment target is 176 participants, below the 12,052-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07221370, a Phase 2 study of Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection, is actively recruiting participants, sponsored by Riverside University Health System Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are: * Does oral vancomycin lower the rate of C.diff infection in high-risk patients? * Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital. Participants will: * Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days. * When discharged from the hospital, participants will continue to take the study medication in the event he/she did not complete the intended course of the study medication while in the hospital. * Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus) * After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.
Primary Outcome
Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction \[PCR\] and stool toxin test) \> 72 hours into hospitalization.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vancomycin 125mg
Study Locations (1)
California
- Riverside University Health System - Moreno Valley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT07221370 shows while recruiting
NCT07221370 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 12,052-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07221370 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07221370 about?
NCT07221370 is a clinical study titled "Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients". The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting...
What is the current status of trial NCT07221370?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2024-10-21. Estimated completion is 2026-12-31.
What conditions does trial NCT07221370 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection, Vancomycin Resistant Enterococci Infection.
What interventions are being tested in trial NCT07221370?
The interventions under investigation include: Placebo (DRUG), Vancomycin 125mg (DRUG).
Who is sponsoring clinical trial NCT07221370?
This trial is sponsored by Riverside University Health System Medical Center, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07221370 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Clostridium Difficile Infection
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 NCT07221370's enrollment target sits among peer trials
176 8th of 13 higher than 6 of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection 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.
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