Treatment Study for 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
- Sex: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I
- Conditions Being Studied: Bacterial Infection
Study Purpose
To measure the blood levels of omadacycline after a single intravenous (IV) or oral dose of omadacycline in children 8 to less than 18 years of age with bacterial infections. • To evaluate the safety and tolerability of a single IV or oral dose of omadacycline in children 8 to less than 18 years of age with bacterial infections.
Who Can Participate
Age: 8-18
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00001579
- StudyID: 2021-0708
- ClinicalTrials.gov: NCT05217537
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