Overview

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.