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COMPLETED Phase 4

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

NCT05515562 · View on ClinicalTrials.gov ↗

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

1,061 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05515562

The ClinicalTrials.gov registry entry for NCT05515562 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05515562 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05515562?

The interventions under investigation include: Omadacycline Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05515562?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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