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Effects of Intravenous (IV) Omadacycline on Gut Microbiome

NCT05515562 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-03-17

Study results available
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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

  • Microbial Colonization

Interventions

DRUG

Omadacycline Injection

All participants will receive Intravenous (IV) omadacycline

Sponsors & Collaborators

  • University of Houston

    collaborator OTHER

  • High Point University

    collaborator OTHER

  • Paratek Pharmaceuticals Inc

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • John C Williamson, PharmD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2023-07-11
Completion
2023-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515562 on ClinicalTrials.gov