Status:
RECRUITING
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
Lead Sponsor:
Paratek Pharmaceuticals Inc
Conditions:
Bacterial Infections
Eligibility:
All Genders
8-17 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05217537
Start Date
April 6 2022
End Date
September 1 2024
Last Update
August 22 2024
Active Locations (9)
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1
Site 109
Little Rock, Arkansas, United States, 72202
2
Site 112
Long Beach, California, United States, 90806
3
Site 107
Orange, California, United States, 92868
4
Site 114
Aurora, Colorado, United States, 80045