← Back to Search

Tetracycline Antibiotic

Omadacycline Oral Tablet for Bacterial Infection

Q: How many participants are engaged in this scientific experiment?

In order to begin the study, Paratek Pharmaceuticals Inc. requires 40 participants who meet the trial's inclusion criteria. The firm is running this experiment from two sites: Site 107 in Orange, <a href="https://www.withpower.com/clinical-trials/california">California</a> and Site 105 in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>.

Q: How widespread is the implementation of this medical experiment in our metropolis?

Five different medical centres are running the trial, including Site 107 in Orange, Site 105 in Chicago, and Site 106 in Cleveland. Additionally, there are two other locations participating.

Q: Are there still opportunities for patients to participate in this investigation?

As indicated on clinicaltrials.gov, this research is presently looking for volunteers. It was first published to the website on April 6th 2022 and updated most recently June 24th of the same year.

Q: To what extent could Omadacycline Oral Tablet pose a hazard to individuals?

The safety of Omadacycline Oral Tablet is assessed as a 1 on our internal scale, due to the limited evidence that has been produced in this Phase 1 trial.

Q: What qualifications must a participant meet to be accepted into this medical trial?

Forty children between the ages of 8 and 17 suffering from bacterial infections are eligible for this medical study.

Q: Are seniors aged 75 and up being considered for participation in the trial?

According to the requirements listed on clinicaltrials.gov, only individuals between 8 and 17 years old are eligible for this trial. There are 206 trials specifically designed for minors while 624 studies focus on elderly patients above 65.

Q: What is the aim of this medical investigation?

This research project measures the pharmacokinetics of a single oral dose of omadacycline in pediatric patients aged 8-18 with confirmed or suspected bacterial infections. Pre-dose, and 0.5, 1, 2, 8, and 24 hour post-dose assessments will be conducted to ascertain this primary outcome. Secondary objectives are also being evaluated through physical examination findings for any clinical abnormalities alongside incidence rate of adverse events and serious adverse events as well as recording abnormal laboratory test results.

Phase 1

Recruiting

Research Sponsored by Paratek Pharmaceuticals Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline

Weight within the 5th and 95th percentile for age and sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

Awards & highlights

Study Summary

This trial will study how well omadacycline works in children with bacterial infections.

Who is the study for?

This trial is for hospitalized children and teens aged 8 to under 18 with suspected or confirmed bacterial infections. They must not be pregnant, agree to birth control if applicable, and fall within the normal weight range for their age and sex. They can't join if they have COVID-19, took experimental drugs recently, have a risky health condition, or are allergic to tetracycline antibiotics.Check my eligibility

What is being tested?

The study tests how a single dose of Omadacycline (either as an oral tablet or injection) behaves in the bodies of young patients with bacterial infections. It aims to understand the correct dosage by observing how the drug is absorbed and processed.See study design

What are the potential side effects?

Omadacycline may cause side effects similar to other antibiotics in its class which include nausea, vomiting, diarrhea, sun sensitivity, yeast infections in females, and possible tooth discoloration in younger children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in the hospital for a bacterial infection and will be treated with antibiotics, not including omadacycline.

Select...

My weight is within the normal range for my age and sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections

Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections

Secondary outcome measures

Adverse events and serious adverse events

Clinical laboratory tests

Physical examination

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (children)Experimental Treatment2 Interventions

8 to < 12 years of age

Group II: Cohort 1 (adolescents)Experimental Treatment2 Interventions

12 to < 18 years of age

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omadacycline Injection [Nuzyra]

2021

Completed Phase 4

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Paratek Pharmaceuticals IncLead Sponsor

16 Previous Clinical Trials

3,973 Total Patients Enrolled

Amy ManleyStudy DirectorParatek Pharmaceuticals Inc

2 Previous Clinical Trials

1,405 Total Patients Enrolled

Media Library

Omadacycline (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05217537 — Phase 1

Bacterial Infection Research Study Groups: Cohort 1 (adolescents), Cohort 2 (children)

Bacterial Infection Clinical Trial 2023: Omadacycline Highlights & Side Effects. Trial Name: NCT05217537 — Phase 1

Omadacycline (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217537 — Phase 1

Frequently Asked Questions

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

How many participants are engaged in this scientific experiment?

"In order to begin the study, Paratek Pharmaceuticals Inc. requires 40 participants who meet the trial's inclusion criteria. The firm is running this experiment from two sites: Site 107 in Orange, California and Site 105 in Chicago, Illinois."

Answered by AI

How widespread is the implementation of this medical experiment in our metropolis?

"Five different medical centres are running the trial, including Site 107 in Orange, Site 105 in Chicago, and Site 106 in Cleveland. Additionally, there are two other locations participating."

Answered by AI

Are there still opportunities for patients to participate in this investigation?

"As indicated on clinicaltrials.gov, this research is presently looking for volunteers. It was first published to the website on April 6th 2022 and updated most recently June 24th of the same year."

Answered by AI

To what extent could Omadacycline Oral Tablet pose a hazard to individuals?

"The safety of Omadacycline Oral Tablet is assessed as a 1 on our internal scale, due to the limited evidence that has been produced in this Phase 1 trial."

Answered by AI

What qualifications must a participant meet to be accepted into this medical trial?

"Forty children between the ages of 8 and 17 suffering from bacterial infections are eligible for this medical study."

Answered by AI

Are seniors aged 75 and up being considered for participation in the trial?

"According to the requirements listed on clinicaltrials.gov, only individuals between 8 and 17 years old are eligible for this trial. There are 206 trials specifically designed for minors while 624 studies focus on elderly patients above 65."

Answered by AI

What is the aim of this medical investigation?

"This research project measures the pharmacokinetics of a single oral dose of omadacycline in pediatric patients aged 8-18 with confirmed or suspected bacterial infections. Pre-dose, and 0.5, 1, 2, 8, and 24 hour post-dose assessments will be conducted to ascertain this primary outcome. Secondary objectives are also being evaluated through physical examination findings for any clinical abnormalities alongside incidence rate of adverse events and serious adverse events as well as recording abnormal laboratory test results."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

2022. "Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05217537.

All > Rsv