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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Omadacycline Injection

Study Locations (1)

North Carolina

  • Wake Forest Baptist Health - Winston-Salem

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-03-20
Est. Completion 2023-07-11
Phase Phase 4

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT05515562

The ClinicalTrials.gov registry entry for NCT05515562 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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