Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
Sponsored by Paratek Pharmaceuticals Inc
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the participation requirements?
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.