Pharmacokinetics and Safety of Solithromycin in Adolescents and Children
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
1 other identifier
interventional
84
2 countries
34
Brief Summary
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2015
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 9, 2017
June 1, 2017
1.8 years
October 15, 2014
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
5 to 7 days
Study Arms (1)
solithromycin
EXPERIMENTALoral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Palo Alto, California, 94305, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Wichita, Kansas, 67214, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Brooklyn, New York, 11203, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Cleveland, Ohio, 44103, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Memphis, Tennessee, 38105-3678, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Austin, Texas, 78723, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Splendora, Texas, 77372, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Morgantown, West Virginia, 26506, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Unknown Facility
Plovdiv, 4002, Bulgaria
Unknown Facility
Rousse, 7002, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Related Publications (2)
Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
PMID: 31318840DERIVEDGonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
PMID: 29891609DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Cohen-Wolkowiez, MD
Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 20, 2014
Study Start
January 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
June 9, 2017
Record last verified: 2017-06