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Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05515562
Collaborator
University of Houston (Other), High Point University (Other), Paratek Pharmaceuticals Inc (Industry)
8
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omadacycline Injection
 Phase 4

Detailed Description

The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of IV Omadacycline on Gut Microbiome
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intravenous (IV) Omadacycline

All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline

Drug: Omadacycline Injection
All participants will receive Intravenous (IV) omadacycline
Other Names:
  • Omadacycline oral

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in gut microbiota concentrations [Day 31]

      In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18-40 years of age

    • Willing and able to comply with all study procedures

    • Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease

    • males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

    Exclusion Criteria:

    • Consumed probiotics within 30 days before enrollment

    • Consumed antibiotics within 90 days prior to enrollment

    • Known hypersensitivity to omadacycline or tetracycline-class antibiotics

    • pregnant or breastfeeding

    • in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study

    • previously participated in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • University of Houston
    • High Point University
    • Paratek Pharmaceuticals Inc

    Investigators

    • Principal Investigator: John C Williamson, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05515562
    Other Study ID Numbers:
    • IRB00081259
    First Posted:
    Aug 25, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Wake Forest University Health Sciences
    Gut Microbiome
    Clostridioides difficile
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections

    Study Results

    No Results Posted as of Aug 25, 2022