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Tetracycline Antibiotic

Omadacycline Injection for Microbial Colonization

Phase 4

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 31

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in gut microbiota concentrations

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of HoustonOTHER

147 Previous Clinical Trials

47,544 Total Patients Enrolled

Paratek Pharmaceuticals IncIndustry Sponsor

16 Previous Clinical Trials

4,005 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,240 Previous Clinical Trials

1,004,199 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research taking into consideration the participation of individuals aged 75 or over?

"This research trial is seeking participants who are between 18 and 40 years old."

Answered by AI

Would I be eligible to join this investigation?

"This clinical trial requires 8 volunteers aged 18 to 40 who are colonized with microbes and meet the following conditions: no prior cardiovascular, gastrointestinal, hepatic or renal illness; female participants of child-bearing potential must consent to using highly reliable contraception during treatment and for at least 7 days post last dose of omadacycline; general good health status."

Answered by AI

What formal approval has Omadacycline Injection acquired?

"With a score of 3, our team has determined Omadacycline Injection to be notably safe due its Phase 4 status and previous approval."

Answered by AI

Does this research initiative still accept new participants?

"As per clinicaltrials.gov, this medical test is no longer recruiting participants; the trial was originally launched on December 1st 2022 and revised lastly on November 28th 2022. While it's not actively seeking patients anymore, there are still 770 other trials that require enrolment currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

2023. "Effects of Intravenous (IV) Omadacycline on Gut Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515562.

All > Microbiome