Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Sponsors

Lead Sponsor: Daniel Benjamin

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC

Source Duke University
Brief Summary

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 7000 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 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.

Overall Status Completed
Start Date 2011-11-01
Completion Date 2019-11-01
Primary Completion Date 2019-11-01
Study Type Observational
Primary Outcome
Measure Time Frame
Composite of pharmacokinetic outcomes for understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary Outcome
Measure Time Frame
Composite pharmacodynamic outcomes of understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days
Biomarkers associated with understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days
Enrollment 3520
Condition
Intervention

Intervention Type: Drug

Intervention Name: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Exclusion Criteria: - 1) Failure to obtain consent/assent (as indicated) - 2) Known pregnancy as determined via interview or testing if available.

Gender:

All

Minimum Age:

N/A

Maximum Age:

21 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Alaska Native Medical Center | Anchorage, Alaska, 99508, United States
Arkansas Children's Hospital | Little Rock, Arkansas, 72202, United States
University of California at San Diego Medical Center | La Jolla, California, 92093, United States
Axis Clinical Trials | Los Angeles, California, 90036, United States
University of California, Los Angeles Medical Center | Los Angeles, California, 90095, United States
The Children's Hospital Colorado | Aurora, Colorado, 80045, United States
Yale New Haven Children's Hospital | New Haven, Connecticut, 06504, United States
Alfred I. DuPont Hospital for Children | Wilmington, Delaware, 19803, United States
Children's National Medical Center | Washington, District of Columbia, 20010, United States
University of Florida Jacksonville Shands Medical Center | Jacksonville, Florida, 32209, United States
Kapiolani Womens and Childrens Medical Center | Honolulu, Hawaii, 96826, United States
Lurie Children's Hospital of Chicago | Chicago, Illinois, 60614, United States
Riley Hospital for Children at Indiana University | Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center | Fairway, Kansas, 66205, United States
Children's Mercy Hospital and Clinics | Kansas City, Kansas, 66160, United States
Wesley Medical Center | Wichita, Kansas, 67214, United States
Norton Children's Hospital | Louisville, Kentucky, 40202, United States
Tulane University Health Science Center | New Orleans, Louisiana, 70112, United States
Ochsner Baptist Clinical Trials Unit | New Orleans, Louisiana, 70115-6969, United States
University of Maryland | Baltimore, Maryland, 21201, United States
Children's Hospital of Michigan | Detroit, Michigan, 48201, United States
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics | Kansas City, Missouri, 64108, United States
University of Montana | Missoula, Montana, 59804, United States
University of Nebraska Medical Center | Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
University of New Mexico, Health Sciences Center | Albuquerque, New Mexico, 87131, United States
UNC Hospital Neonatal-Perinatal Medicine | Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center (PICU / NICU) | Durham, North Carolina, 27710, United States
Cincinnati Childrens Hospital Medical Center | Cincinnati, Ohio, 45229-3039, United States
Rainbow Babies and Children's Hospital | Cleveland, Ohio, 44106, United States
Akron Children's Hospital | Cleveland, Ohio, 44313, United States
Board of Regents of the University of Oklahoma | Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University | Portland, Oregon, 97201-2701, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
Medical University of South Carolina | Charleston, South Carolina, 29425, United States
University of South Carolina | Columbia, South Carolina, 29203, United States
University of Utah Hospitals and Clinics | Salt Lake City, Utah, 84108, United States
University of Vermont Medical Center | Burlington, Vermont, 05405, United States
University of Virginia Children's Hospital | Charlottesville, Virginia, 22908-0386, United States
Seattle Children's Hospital | Seattle, Washington, 98105, United States
West Virginia University Hospital | Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States
Manitoba Institute of Child Health | Winnipeg, Manitoba, R3E 3P4, Canada
Children's Hospital of Eastern Ontario | Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children | Toronto, Ontario, M5G 1X8, Canada
Hospital Sainte-Justine | Montreal, Quebec, T3T 1C5, Canada
Assaf Harofeh Medical Center | Zerifin, Tel Aviv, 70300, Israel
Schneider Children's Medical Center of Israel | Petah Tikva, 49202, Israel
KK Women's and Children's Hospital Pte Ltd | Singapore, 229899, Singapore
Southampton General Hospital | Southampton, Hampshire, SO16 6YD, United Kingdom
Alder Hey Children's Hospital | Liverpool, Merseyside, L12 2AP, United Kingdom
Location Countries

Canada

Israel

Singapore

United Kingdom

United States

Verification Date

2019-12-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Duke University

Investigator Full Name: Daniel Benjamin

Investigator Title: Professor of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Acronym PTN_POPS
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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