Overview

Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cempra Inc
Melinta Therapeutics, Inc.
Collaborator:
Department of Health and Human Services
Treatments:
Solithromycin
Criteria
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