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

Paratek

Status and phase: Enrolling; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05217537

PTK0796-PEDPK-20110

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort 1 (adolescents)

Experimental group

Description:

12 to \< 18 years of age

Treatment:

Drug: Omadacycline Oral Tablet

Drug: Omadacycline Injection [Nuzyra]

Cohort 2 (children)

Experimental group

Description:

8 to \< 12 years of age

Treatment:

Drug: Omadacycline Oral Tablet

Drug: Omadacycline Injection [Nuzyra]