Clinical trial NCT05217537: Study to Evaluate the PK of IV and PO 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
measure: 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
timeFrame: Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose
Secondary outcomes:
measure: Adverse events and serious adverse events
timeFrame: From the time of signing the informed consent form up to study completion visit (up to 9 days)
measure: Clinical laboratory tests
timeFrame: From the time of signing the informed consent form up to study completion visit (up to 9 days)
measure: Vital signs
timeFrame: From the time of signing the informed consent form up to study completion visit (up to 9 days)
measure: Physical examination
timeFrame: From the time of signing the informed consent form up to study completion visit (up to 9 days)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site 109
state: Arkansas
city: Long Beach
country: United States
facility: Site 112
state: California
city: Orange
country: United States
facility: Site 107
state: California
city: Aurora
country: United States
facility: Site 114
state: Colorado
city: Chicago
country: United States
facility: Site 105
state: Illinois
city: Greenville
country: United States
facility: Site 111
state: North Carolina
city: Cleveland
country: United States
facility: Site 106
state: Ohio
city: Philadelphia
country: United States
facility: Site 113
state: Pennsylvania
city: Houston
country: United States
facility: Site 108
state: Texas
Study officials:
affiliation: Paratek Pharmaceuticals Inc
name: Amy Manley
role: STUDY_DIRECTOR
References: