Omadacycline for Bacterial Infections

Recruiting at 8 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Paratek Pharmaceuticals Inc

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.

Research Team

Amy Manley

Principal Investigator

Paratek Pharmaceuticals Inc

Eligibility Criteria

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.

Inclusion Criteria

Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study

I am between 8 and 17 years old and have consent from a parent or legal guardian.

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

Exclusion Criteria

Received an investigational drug within the past 30 days

I have or might have COVID-19.

History of hypersensitivity or allergic reaction to any tetracycline antibiotic

Treatment Details

Interventions

• Omadacycline (Tetracycline Antibiotic)

Trial Overview 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.

Participant Groups

Group I: Cohort 2 (children) Experimental Treatment 2 Interventions

8 to \< 12 years of age

Group II: Cohort 1 (adolescents) Experimental Treatment 2 Interventions

12 to \< 18 years of age

Who Is Running the Clinical Trial?

Paratek Pharmaceuticals Inc

Lead Sponsor

Trials

17

Recruited

4,000+