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NCT05217537

Study to Evaluate the PK of IV and PO 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
Paratek Pharmaceuticals Inc·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Bacterial Infections
Drug/Device/Intervention
Omadacycline Injection [Nuzyra]
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Paratek Pharmaceuticals Inc
Location
Little Rock,Orange,Chicago,Greenville,Cleveland,Houston, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Apr 06, 2022
End date
Nov 01, 2023
Enrollment
40 participants
Primary outcome

Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to 18 years of age with suspected or confirmed bacterial infections,Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to 18 years of age with suspected or confirmed bacterial infections

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.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05217537
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05217537 through Pure Global AI's free database. This Phase 1 trial is sponsored by Paratek Pharmaceuticals Inc and is currently Recruiting. The study focuses on Bacterial Infections. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.