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Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections - Trial NCT05217537

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.

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NCT05217537
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05217537
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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

Study Focus

Bacterial Infections

Omadacycline Injection [Nuzyra]

Interventional

drug

Sponsor & Location

Paratek Pharmaceuticals Inc

Little Rock,Orange,Chicago,Greenville,Cleveland,Houston, United States of America

Timeline & Enrollment

Phase 1

Apr 06, 2022

Nov 01, 2023

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, unspecified
Bacterial, viral and other infectious agents
Other bacterial intestinal infections
Other bacterial diseases
Other specified bacterial intestinal infections

Data Source

ClinicalTrials.gov

NCT05217537

Non-Device Trial