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

Primary Purpose

Bacterial Infections

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omadacycline Injection [Nuzyra]
Omadacycline Oral Tablet
Sponsored by
Paratek Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bacterial Infections

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 109Recruiting
  • Site 107Recruiting
  • Site 105Recruiting
  • Site 111Recruiting
  • Site 106Recruiting
  • Site 108Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 (adolescents)

Cohort 2 (children)

Arm Description

12 to < 18 years of age

8 to < 12 years of age

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Adverse events and serious adverse events
Incidence, severity, and type of adverse events and serious adverse events
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Vital signs
Number of participants with clinically significant changes from baseline in vital signs
Physical examination
Number of participants with clinically significant abnormal physical examination findings

Full Information

First Posted
December 15, 2021
Last Updated
April 12, 2023
Sponsor
Paratek Pharmaceuticals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05217537
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (adolescents)
Arm Type
Experimental
Arm Description
12 to < 18 years of age
Arm Title
Cohort 2 (children)
Arm Type
Experimental
Arm Description
8 to < 12 years of age
Intervention Type
Drug
Intervention Name(s)
Omadacycline Injection [Nuzyra]
Other Intervention Name(s)
NUZYRA
Intervention Description
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
Intervention Type
Drug
Intervention Name(s)
Omadacycline Oral Tablet
Other Intervention Name(s)
NUZYRA
Intervention Description
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)
Primary Outcome Measure Information:
Title
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
Description
Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
Time Frame
Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
Title
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
Description
Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
Time Frame
Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose
Secondary Outcome Measure Information:
Title
Adverse events and serious adverse events
Description
Incidence, severity, and type of adverse events and serious adverse events
Time Frame
From the time of signing the informed consent form up to study completion visit (up to 9 days)
Title
Clinical laboratory tests
Description
Number of participants with abnormal clinical laboratory tests
Time Frame
From the time of signing the informed consent form up to study completion visit (up to 9 days)
Title
Vital signs
Description
Number of participants with clinically significant changes from baseline in vital signs
Time Frame
From the time of signing the informed consent form up to study completion visit (up to 9 days)
Title
Physical examination
Description
Number of participants with clinically significant abnormal physical examination findings
Time Frame
From the time of signing the informed consent form up to study completion visit (up to 9 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Kirsch
Phone
4847514925
Email
courtney.kirsch@paratekpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Manley
Email
amy.manley@paratekpharma.com
Facility Information:
Facility Name
Site 109
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snowden
Facility Name
Site 107
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arrieta
Facility Name
Site 105
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mueller
Facility Name
Site 111
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 106
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desai
Facility Name
Site 108
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heresi

12. IPD Sharing Statement

Plan to Share IPD
No

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

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