Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc

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.