Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
Completed · Phase 1
Conditions studied: Bacterial Infections
In brief
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.
Key facts
- Study ID
- NCT05217537
- Run by
- Paratek Pharmaceuticals Inc
- People needed
- 23
- Starts
- 2022-04-06
- Expected to finish
- 2025-02-27
- Last updated by the study team
- 2026-03-09
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Site 109 — Little Rock, Arkansas, United States
- Site 112 — Long Beach, California, United States
- Site 107 — Orange, California, United States
- Site 114 — Aurora, Colorado, United States
- Site 105 — Chicago, Illinois, United States
- Site 111 — Greenville, North Carolina, United States
- Site 106 — Cleveland, Ohio, United States
- Site 113 — Philadelphia, Pennsylvania, United States
- Site 108 — Houston, Texas, United States
Full record on ClinicalTrials.gov
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