Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Microbial Colonization Clinical Trial

Official title:

Effects of IV Omadacycline on Gut Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515562
• Other study ID #: IRB00081259
• Status: Recruiting
• Phase: Phase 4
• Start date: March 20, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Yolanda Belin
• Phone: 336-716-3720
• Email: ybelin[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	High Point University, Paratek Pharmaceuticals Inc, University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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