Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
NCT ID: NCT05217537
Last Updated: 2024-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2022-04-06
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort 1 (adolescents)
12 to \< 18 years of age
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)
Cohort 2 (children)
8 to \< 12 years of age
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
8 Years
17 Years
ALL
No
Sponsors
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Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Manley
Role: STUDY_DIRECTOR
Paratek Pharmaceuticals Inc
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Snowden
Role: primary
Deveikis
Role: primary
Arrieta
Role: primary
Haynes
Role: primary
Mueller
Role: primary
Syed
Role: primary
Desai
Role: primary
Downes
Role: primary
Perez
Role: primary
Other Identifiers
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PTK0796-PEDPK-20110
Identifier Type: -
Identifier Source: org_study_id
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