RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-06
Study Completion:2024-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05217537

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.

Ages Eligible for Study:8 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects, age 8 to \< 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
  2. * Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
  3. * Weight within the 5th and 95th percentile for age and sex.
  4. * 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
  1. * Evidence of a medical condition that may pose a safety risk or impair study participation.
  2. * Confirmed or suspected SARS-CoV-2 infection.
  3. * Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
  4. * Has received an investigational drug within the past 30 days.

Contacts and Locations

Study Contact

Courtney Kirsch
CONTACT
4847514925
courtney.kirsch@paratekpharma.com
Amy Manley
CONTACT
amy.manley@paratekpharma.com

Principal Investigator

Amy Manley
STUDY_DIRECTOR
Paratek Pharmaceuticals Inc

Study Locations (Sites)

Site 109
Little Rock, Arkansas, 72202
United States
Site 112
Long Beach, California, 90806
United States
Site 107
Orange, California, 92868
United States
Site 114
Aurora, Colorado, 80045
United States
Site 105
Chicago, Illinois, 60611
United States
Site 111
Greenville, North Carolina, 27858
United States
Site 106
Cleveland, Ohio, 60611
United States
Site 113
Philadelphia, Pennsylvania, 19104
United States
Site 108
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Paratek Pharmaceuticals Inc

  • Amy Manley, STUDY_DIRECTOR, Paratek Pharmaceuticals Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-06
Study Completion Date2024-09

Study Record Updates

Study Start Date2022-04-06
Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

  • Bacterial Infections