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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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
32
sites
Clinical Trial Facility in Plovdiv
Plovdiv,
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Clinical Trial Facility in Albany New York
Albany, New York 12205
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Albany, NY
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Clinical Trial Facility in Albuquerque New Mexico
Albuquerque, New Mexico
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Albuquerque, NM
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Austin, TX
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, MD
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Clinical Trial Facility in Brooklyn New York
Brooklyn, New York 11215
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Brooklyn, NY
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Clinical Trial Facility in Chapel Hill North Carolina
Chapel Hill, North Carolina
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Chapel Hill, NC
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Cleveland Ohio
Cleveland, Ohio
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Cleveland, OH
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Clinical Trial Facility in Hackensack New Jersey
Hackensack, New Jersey 07601
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Hackensack, NJ
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Iowa City Iowa
Iowa City, Iowa 52242
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Iowa City, IA
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Clinical Trial Facility in Jacksonville Florida
Jacksonville, Florida 32209
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Jacksonville, FL
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Little Rock, AR
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Clinical Trial Facility in Louisville Kentucky
Louisville, Kentucky 40202
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Louisville, KY
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Clinical Trial Facility in Memphis Tennessee
Memphis, Tennessee
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Memphis, TN
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Clinical Trial Facility in Morgantown West Virginia
Morgantown, West Virginia
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Morgantown, WV
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in Omaha Nebraska
Omaha, Nebraska
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Omaha, NE
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Clinical Trial Facility in Orange California
Orange, California 92868
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Orange, CA
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Clinical Trial Facility in Palo Alto California
Palo Alto, California 94301
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Palo Alto, CA
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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Clinical Trial Facility in Richmond Virginia
Richmond, Virginia 23227
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Richmond, VA
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Clinical Trial Facility in San Diego California
San Diego, California
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San Diego, CA
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Clinical Trial Facility in Seattle Washington
Seattle, Washington 98105
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Seattle, WA
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Clinical Trial Facility in Shreveport Louisiana
Shreveport, Louisiana 71103
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Shreveport, LA
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Clinical Trial Facility in Splendora Texas
Splendora, Texas 77372
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Splendora, TX
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Clinical Trial Facility in St. Louis Missouri
St. Louis, Missouri 63104
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St. Louis, MO
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Clinical Trial Facility in Tampa Florida
Tampa, Florida
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Tampa, FL
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Clinical Trial Facility in Toledo Ohio
Toledo, Ohio 43608
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Toledo, OH
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Clinical Trial Facility in Wichita Kansas
Wichita, Kansas 67214
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Wichita, KS
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