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Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Primary Purpose

Microbial Colonization

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omadacycline Injection

About this trial

This is an interventional treatment trial for Microbial Colonization focused on measuring Gut Microbiome, Clostridioides difficile

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wake Forest Baptist HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous (IV) Omadacycline

Arm Description

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

Outcomes

Primary Outcome Measures

Change in gut microbiota concentrations

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05515562

First Posted

August 23, 2022

Last Updated

March 22, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

University of Houston, High Point University, Paratek Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT05515562

Brief Title

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Official Title

Effects of IV Omadacycline on Gut Microbiome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

University of Houston, High Point University, Paratek Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microbial Colonization

Keywords

Gut Microbiome, Clostridioides difficile

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous (IV) Omadacycline

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omadacycline Injection

Other Intervention Name(s)

Omadacycline oral

Intervention Description

All participants will receive Intravenous (IV) omadacycline

Primary Outcome Measure Information:

Title

Change in gut microbiota concentrations

Description

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

Time Frame

Day 31

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yolanda Belin

Phone

336-716-3720

ybelin@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John C Williamson

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John C Williamson, PharmD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD that underlie the results reported in this article, after deidentification

IPD Sharing Time Frame

Beginning 6 months following article publication and ending 36 months following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

Learn more about this trial

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

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