Status:
COMPLETED
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
Lead Sponsor:
Melinta Therapeutics, Inc.
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Bacterial Infection
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE1
Brief Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Eligibility Criteria
Inclusion
- Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.
Exclusion
- Serum creatinine \>2 mg/dL
- Positive pregnancy test in females of childbearing potential
- History of intolerance or hypersensitivity to macrolide antibiotics
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02268279
Start Date
January 1 2015
End Date
October 1 2016
Last Update
June 9 2017
Active Locations (34)
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1
Little Rock, Arkansas, United States, 72202
2
Orange, California, United States, 92868
3
Palo Alto, California, United States, 94305
4
San Diego, California, United States, 92123