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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217537
• Other study ID #: PTK0796-PEDPK-20110
• Status: Recruiting
• Phase: Phase 1
• Start date: April 6, 2022
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Paratek Pharmaceuticals Inc
• Contact: Courtney Kirsch
• Phone: 4847514925
• Email: courtney.kirsch[@]paratekpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections

Intervention

Drug:
• Omadacycline Injection [Nuzyra]
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
• Omadacycline Oral Tablet
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)

Locations

Country	Name	City	State
United States	Site 105	Chicago	Illinois
United States	Site 106	Cleveland	Ohio
United States	Site 111	Greenville	North Carolina
United States	Site 108	Houston	Texas
United States	Site 109	Little Rock	Arkansas
United States	Site 112	Long Beach	California
United States	Site 107	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Paratek Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2	Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
Primary	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	Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2	Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose
Secondary	Adverse events and serious adverse events	Incidence, severity, and type of adverse events and serious adverse events	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Secondary	Clinical laboratory tests	Number of participants with abnormal clinical laboratory tests	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Secondary	Vital signs	Number of participants with clinically significant changes from baseline in vital signs	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Secondary	Physical examination	Number of participants with clinically significant abnormal physical examination findings	From the time of signing the informed consent form up to study completion visit (up to 9 days)