Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Completed · Phase 1

Conditions studied: Bacterial Infection

In brief

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

Key facts

Study ID

NCT02268279

Run by

Melinta Therapeutics, Inc.

People needed

84

Starts

2015-01-01

Expected to finish

2016-10-01

Last updated by the study team

2017-06-09

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Serum creatinine >2 mg/dL
• Positive pregnancy test in females of childbearing potential
• History of intolerance or hypersensitivity to macrolide antibiotics

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albany, New York, United States
• Study site — Brooklyn, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Memphis, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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