Effects of Intravenous (IV) Omadacycline on Gut Microbiome

NCT05515562 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00081259
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Keywords

Gut Microbiome; Clostridioides difficile

Outcome Measures

Primary Outcomes (11)

• Phylum Level Mean Proportional Relative Abundance

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

  Day 30

• Phylum Level Mean Proportional Relative Abundance

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

  Baseline

• Phylum Level Mean Proportional Relative Abundance

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

  Day 5

• Phylum Level Mean Proportional Relative Abundance

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

  Day 10

• Bacterial DNA Per Gram of Stool

  nanograms (ng) per gram of stool for bacterial DNA

  Baseline

• Bacterial DNA Per Gram of Stool

  nanograms (ng) per gram of stool for bacterial DNA

  During Therapy up to Day 6

• Bacterial DNA Per Gram of Stool

  nanograms (ng) per gram of stool for bacterial DNA

  End of Therapy up to Day 10

• Order Level Mean Proportional Relative Abundance

  Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  Baseline

• Order Level Mean Proportional Relative Abundance

  Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  Day 5

• Order Level Mean Proportional Relative Abundance

  Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  Day 10

• Order Level Mean Proportional Relative Abundance

  Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  Day 30

Study Arms (1)

Intravenous (IV) Omadacycline

EXPERIMENTAL

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

Drug: Omadacycline Injection

Interventions

Omadacycline Injection DRUG

All participants will receive Intravenous (IV) omadacycline

Also known as: Omadacycline oral

Intravenous (IV) Omadacycline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

omadacycline

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Williamson, PharmD
• Organization: Wake Forest University Health Sciences

johnwill@wakehealth.edu

336.713.3431

Study Officials

• John C Williamson, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: March 20, 2023
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months following article publication and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)