Last updated on March 2017

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care


Brief description of study

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 3000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Detailed Study Description

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol. Aim #1: Evaluate the PK of understudied drugs currently being administered to children. Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population. Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children. Hypothesis #2: The PD of targeted drugs in children will differ from adults. Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on therapeutic exposure. Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic profiles will impact drug exposure in children.

Clinical Study Identifier: NCT01431326

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Laura James, MD

Arkansas Children's Hospital
Little Rock, AR United States
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Chiara Melloni, MD

University of California at San Diego Medical Center
La Jolla, CA United States
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Chiara Melloni, MD

Axis Clinical Trials
Los Angeles, CA United States
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Jaime Deville, MD

University of California, Los Angeles Medical Center
Los Angeles, CA United States
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Peter Mourani, MD

The Children's Hospital Colorado
Aurora, CO United States
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Matthew Bizzarro, MD

Yale New Haven Children's Hospital
New Haven, CT United States
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Marisa Meyer, MD

Alfred I. DuPont Hospital for Children
Wilmington, DE United States
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John van den Anker, MD, ...

Children's National Medical Center
Washington, WA United States
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Mobeen Rathore, MD

University of Florida Jacksonville Shands Medical Center
Jacksonville, FL United States
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Ram Yogev, MD

Lurie Children's Hospital of Chicago
Chicago, IL United States
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Sokol Gregory, MD,

Riley Hospital for Children at Indiana University
Indianapolis, IN United States
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Paula Delmore, MSN

Wesely Medical Center
Wichita, KS United States
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Janice Sullivan, MD, FAAP, FCCM, ...

Norton Children's Hospital
Louisville, KY United States
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Chiara Melloni, MD

University of Maryland
Baltimore, MD United States
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Chiara Melloni, MD

Children's Hospital of Michigan
Detroit, MI United States
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Chiara Melloni, MD

Children's Mercy Hospitals and Clinics
Kansas City, MO United States
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Matthew Laughon, MD, MPH

UNC Hospital Neonatal-Perinatal Medicine
Chapel Hill, NC United States
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Hornik Chi, PharmD

Duke University Medical Center (PICU / NICU)
Durham, NC United States
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Stuart Goldstein, MD

Cincinnati Childrens Hospital Medical Center
Cincinnati, OH United States
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David Speicher, MD

Rainbow Babies and Children's Hospital
Cleveland, OH United States
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Chiara Melloni, MD

Akron Children's Hospital
Cleveland, OH United States
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Amira Al-Uzri, MD

Oregon Health and Science University
Portland, OR United States
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Andrew Atz, MD

Medical University of South Carolina
Charleston, SC United States
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Catherine Sherwin, MD

University of Utah Hospitals and Clinics
Salt Lake City, UT United States
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Chiara Melloni, MD

University of Virginia Children's Hospital
Charlottesville, VA United States
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Joseph Flynn, MD

Seattle Children's Hospital
Seattle, WA United States
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Beth Drolet, MD

Medical College of Wisconsin
Milwaukee, WI United States
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Geert T'Jong, MD

Manitoba Institute of Child Health
Winnipeg, MB Canada
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Hugh McMillan, MD

Children's Hospital of Eastern Ontario
Ottawa, ON Canada
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Yaron Finkelstein, MD

The Hospital for Sick Children
Toronto, ON Canada
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Julie Autmizguine, MD

Hospital Sainte-Justine
Montreal, QC Canada
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Matitiahu Berkovitch, MD

Assaf Harofeh Medical Center
Zerifin, Israel
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Yehezkel (Hezi) Waisman, MD

Schneider Children's Medical Center of Israel
Petah Tikva, Israel
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Jan Hau Lee, MD

KK Women's and Children's Hospital Pte Ltd
Singapore, Singapore
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Iain Macintosh, MD

Southampton General Hospital
Southampton, United Kingdom
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