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

Description

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.

Conditions

Bacterial Infections

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Study Overview

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Study Details

Study 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.

A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects 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

Condition
Bacterial Infections
Intervention / Treatment

-

Contacts and Locations

Little Rock

Site 109, Little Rock, Arkansas, United States, 72202

Long Beach

Site 112, Long Beach, California, United States, 90806

Orange

Site 107, Orange, California, United States, 92868

Aurora

Site 114, Aurora, Colorado, United States, 80045

Chicago

Site 105, Chicago, Illinois, United States, 60611

Greenville

Site 111, Greenville, North Carolina, United States, 27858

Cleveland

Site 106, Cleveland, Ohio, United States, 60611

Philadelphia

Site 113, Philadelphia, Pennsylvania, United States, 19104

Houston

Site 108, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

8 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Paratek Pharmaceuticals Inc,

Amy Manley, STUDY_DIRECTOR, Paratek Pharmaceuticals Inc

Study Record Dates

2024-09