Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
- Conditions
- Bacterial Infections
- Interventions
- Registration Number
- NCT05217537
- Lead Sponsor
- Paratek Pharmaceuticals Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (adolescents) Omadacycline Oral Tablet 12 to \< 18 years of age Cohort 1 (adolescents) Omadacycline Injection [Nuzyra] 12 to \< 18 years of age Cohort 2 (children) Omadacycline Oral Tablet 8 to \< 12 years of age Cohort 2 (children) Omadacycline Injection [Nuzyra] 8 to \< 12 years of age
- Primary Outcome Measures
Name Time Method 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 Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
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 Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
- Secondary Outcome Measures
Name Time Method Physical examination From the time of signing the informed consent form up to study completion visit (up to 9 days) Number of participants with clinically significant abnormal physical examination findings
Adverse events and serious adverse events From the time of signing the informed consent form up to study completion visit (up to 9 days) Incidence, severity, and type of adverse events and serious adverse events
Vital signs From the time of signing the informed consent form up to study completion visit (up to 9 days) Number of participants with clinically significant changes from baseline in vital signs
Clinical laboratory tests From the time of signing the informed consent form up to study completion visit (up to 9 days) Number of participants with abnormal clinical laboratory tests
Trial Locations
- Locations (9)
Site 109
🇺🇸Little Rock, Arkansas, United States
Site 112
🇺🇸Long Beach, California, United States
Site 107
🇺🇸Orange, California, United States
Site 114
🇺🇸Aurora, Colorado, United States
Site 105
🇺🇸Chicago, Illinois, United States
Site 111
🇺🇸Greenville, North Carolina, United States
Site 106
🇺🇸Cleveland, Ohio, United States
Site 113
🇺🇸Philadelphia, Pennsylvania, United States
Site 108
🇺🇸Houston, Texas, United States
Site 109🇺🇸Little Rock, Arkansas, United StatesSnowdenContact