Pharmacokinetics and Safety of Solithromycin in Adolescents and Children



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:January 2015
Contact:Robert Hernandez, PhD
Email:rhernandez@cempra.com
Phone:919-313-3571

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A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and
intravenous) in children ages 0 to 17


Inclusion Criteria:

- Suspected or confirmed bacterial infection with organisms against which solithromycin
is expected to be active.

Exclusion Criteria:

- Serum creatinine >2 mg/dL

- Positive pregnancy test in females of childbearing potential

- History of intolerance or hypersensitivity to macrolide antibiotics
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