Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
- Conditions
- Bacterial Infections
- Registration Number
- NCT05217537
- Lead Sponsor
- Paratek Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female subjects, age 8 to < 18 (inclusive) who have written and signed<br> parental/legal authorized representative (LAR) informed consent and pediatric<br> assent.<br><br> - Currently hospitalized with a suspected or confirmed bacterial infection and<br> receiving or planned to receive systemic antibiotic therapy other than omadacycline.<br><br> - Weight within the 5th and 95th percentile for age and sex.<br><br> - Subjects must not be pregnant or nursing at the time of enrollment, and must agree<br> to use a highly effective birth control method during the study<br><br>Exclusion Criteria:<br><br> - Evidence of a medical condition that may pose a safety risk or impair study<br> participation.<br><br> - Confirmed or suspected SARS-CoV-2 infection.<br><br> - Has a history of hypersensitivity or allergic reaction to any tetracycline<br> antibiotic.<br><br> - Has received an investigational drug within the past 30 days.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Adverse events and serious adverse events;Clinical laboratory tests;Vital signs;Physical examination