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 |
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
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
We found this trial at
32
sites
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