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Tetracycline Antibiotic

Omadacycline Injection for Microbial Colonization

Phase 4
Waitlist Available
Led By John C Williamson
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 31
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will study the effects of a new antibiotic on the gut microbiome of healthy volunteers.

Who is the study for?
Healthy volunteers aged 18-40, without cardiovascular, gastrointestinal, hepatic, or renal diseases. Women must use effective contraception during and for a week after the study. Excluded are those who've taken antibiotics or probiotics recently, have hypersensitivity to omadacycline/tetracyclines, are pregnant/breastfeeding, or show signs of acute illness.
What is being tested?
The trial is testing the effects of IV Omadacycline on the gut microbiome in healthy individuals. It aims to find better antibiotic treatments that consider how they affect gut bacteria related to C. difficile infection.
What are the potential side effects?
While specific side effects aren't listed here, common ones for antibiotics like Omadacycline may include digestive upset (like diarrhea), potential allergic reactions for those with sensitivities to tetracyclines, and possibly impacts on beneficial gut bacteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 31
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 31 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in gut microbiota concentrations

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intravenous (IV) OmadacyclineExperimental Treatment1 Intervention
All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omadacycline Injection
2023
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

University of HoustonOTHER
151 Previous Clinical Trials
47,925 Total Patients Enrolled
Paratek Pharmaceuticals IncIndustry Sponsor
16 Previous Clinical Trials
3,996 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,399 Previous Clinical Trials
2,460,191 Total Patients Enrolled
High Point UniversityOTHER
13 Previous Clinical Trials
1,367 Total Patients Enrolled
John C WilliamsonPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Omadacycline Injection (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05515562 — Phase 4
Microbial Colonization Research Study Groups: Intravenous (IV) Omadacycline
Microbial Colonization Clinical Trial 2023: Omadacycline Injection Highlights & Side Effects. Trial Name: NCT05515562 — Phase 4
Omadacycline Injection (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515562 — Phase 4
~3 spots leftby Dec 2025
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