Omadacycline Injection for Microbial Colonization

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Wake Forest Baptist Health, Winston-Salem, NC
Microbial Colonization+2 More
Omadacycline Injection - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Microbial Colonization

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Microbial Colonization

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Day 31

Day 31
Change in gut microbiota concentrations

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Microbial Colonization

Trial Design

1 Treatment Group

Intravenous (IV) Omadacycline
1 of 1
Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: Omadacycline Injection · No Placebo Group · Phase 4

Intravenous (IV) Omadacycline
Drug
Experimental Group · 1 Intervention: Omadacycline Injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 31
Closest Location: Wake Forest Baptist Health · Winston-Salem, NC
Photo of nc wake forest baptist health  1Photo of nc wake forest baptist health  2
2009First Recorded Clinical Trial
1 TrialsResearching Microbial Colonization
142 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.