Evaluating omadacycline in children with bacterial infections

A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections

This study is testing how well a new antibiotic called omadacycline works in children and teens with bacterial infections who are in the hospital.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: Paratek Pharmaceuticals Inc (Industry-sponsored)
• Locations: 9 sites (Little Rock, Arkansas and 8 other locations)
• Trial ID: NCT05217537 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of a single dose of omadacycline, administered either intravenously or orally, in children and adolescents aged 8 to under 18 years who are hospitalized with suspected or confirmed bacterial infections. Participants will receive systemic antibiotic therapy other than omadacycline, allowing researchers to assess how the drug is processed in their bodies. The study aims to gather important data on the safety and effectiveness of omadacycline in this specific pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized children and adolescents aged 8 to under 18 years with suspected or confirmed bacterial infections.

Not a fit: Patients with a history of hypersensitivity to tetracycline antibiotics or those with certain medical conditions that pose safety risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safe and effective use of omadacycline for treating bacterial infections in children and adolescents.

How similar studies have performed: While this study focuses on a specific age group and drug, similar pharmacokinetic studies have shown promise in evaluating new treatments for bacterial infections in pediatric populations.

Eligibility criteria

Inclusion Criteria:

* Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
* 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.
* 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

Exclusion Criteria:

* Evidence of a medical condition that may pose a safety risk or impair study participation.
* Confirmed or suspected SARS-CoV-2 infection.
* Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
* Has received an investigational drug within the past 30 days.

Where this trial is running

Little Rock, Arkansas and 8 other locations

• Site 109 — Little Rock, Arkansas, United States (Recruiting)
• Site 112 — Long Beach, California, United States (Recruiting)
• Site 107 — Orange, California, United States (Recruiting)
• Site 114 — Aurora, Colorado, United States (Recruiting)
• Site 105 — Chicago, Illinois, United States (Recruiting)
• Site 111 — Greenville, North Carolina, United States (Recruiting)
• Site 106 — Cleveland, Ohio, United States (Recruiting)
• Site 113 — Philadelphia, Pennsylvania, United States (Recruiting)
• Site 108 — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Courtney Kirsch

Conditions Bacterial Infections