Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Effects of 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 volunteers.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization
• Intervention / Treatment: Drug: Omadacycline Injection

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 Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yolanda Belin; Phone Number: 336-716-3720; Email: ybelin@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Health
      • Contact: John C Williamson, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 31

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: High Point University; University of Houston; Paratek Pharmaceuticals Inc
• Investigators: Principal Investigator: John C Williamson, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Gut Microbiome; Clostridioides difficile
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: IRB00081259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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