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NCT05515562 · ClinicalTrials.gov registry record · Phase 4
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
A Phase 4 study of Microbial Colonization, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05515562: Completed Phase 4 study of Microbial Colonization, sponsored by Wake Forest University Health Sciences.
NCT05515562 is a Phase 4 study of Microbial Colonization that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 8 participants, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05515562, a Phase 4 study of Microbial Colonization, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.
Primary Outcome
In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Conditions Studied
Interventions
- DRUG Omadacycline Injection
Study Locations (1)
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-03-20 |
| Est. Completion | 2023-07-11 |
| Phase | Phase 4 |
What the finished NCT05515562 record still lists
NCT05515562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Microbial Colonization appearing as the primary indexed condition, and to 1 intervention - of which Omadacycline Injection is the first listed.
NCT05515562 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05515562 about?
NCT05515562 is a clinical study titled "Effects of Intravenous (IV) Omadacycline on Gut Microbiome". Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteer...
What is the current status of trial NCT05515562?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2023-03-20. Estimated completion is 2023-07-11.
What conditions does trial NCT05515562 study?
This clinical trial studies the following conditions: Microbial Colonization.
What interventions are being tested in trial NCT05515562?
The interventions under investigation include: Omadacycline Injection (DRUG).
Who is sponsoring clinical trial NCT05515562?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05515562 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05515562's enrollment target sits among peer trials
8 21st of 20 the lowest of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization 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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