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

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

Recruiting
8-17 years
All
Phase 1
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Overview

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

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.

Study details
    Bacterial Infections

NCT05217537

Paratek Pharmaceuticals Inc

21 February 2024

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