Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Description

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 500 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).

Study Start Date

November 2011

Estimated Completion Date

February 2017

Interventions

  • Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
  • Drug: Ampicillin

Specialties

  • Cardiology: Hypertension
  • Pediatrics: Clinical Pharmacology
  • Pharmacy: Cardiac/Hypertension

MeSH Terms

  • Ampicillin
  • Hypertension

Study ID

Duke University -- Pro00029638

Status

Unknown

Trial ID

NCT01431326

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

3000

Sponsor

Duke University

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

Both

Ages

21 Years and younger

Accepts Healthy Volunteers

No

Study Locations and Contact Information (32)

Study Location Distance Name Phone Email
Yale New Haven Childrens Hospital - New Haven, Connecticut 16.1 miles None None None
Alfred I DuPont Hospital for Children - Wilmington, Delaware 155.5 miles None None None
University of Maryland - Baltimore, Maryland 222.5 miles None None None
Childrens National Medical Center - Washington, District of Columbia 255.3 miles None None None
Case Western University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles Ramon Adams 216-844-5112 ramon.adams@uhhospitals.org
Case Western University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles None None None
Akron Childrens Hospital - Cleveland, Ohio 435.1 miles None None None
Akron Childrens Hospital - Cleveland, Ohio 435.1 miles Heather Anthony RN 330-543-0731 hanthony@chmca.org
Duke University Medical Center - Durham, North Carolina 474.7 miles None None None
UNC Hospital NeonatalPerinatal Medicine - Chapel Hill, North Carolina 482.1 miles None None None
Childrens Hospital of Michigan - Detroit, Michigan 512.3 miles None None None
Riley Hospital for Children at Indiana University - Indianapolis, Indiana 686.4 miles Lucy Smiley 317-278-7364 lcsmiley@iu.edu
Riley Hosptial for Children at Indiana University - Indianapolis, Indiana 686.4 miles None None None
Medical University of South Carolina - Charleston, South Carolina 691.2 miles Al Sarraf Layla 843-792-5309 alsarral@musc.edu
Medical University of South Carolina - Charleston, South Carolina 691.2 miles None None None
Kosair Childrens Hospital - Louisville, Kentucky 696.1 miles None None None
Childrens Memorial Hospital - Chicago, Illinois 747.2 miles None None None
Lurie Childrens Hospital of Chicago - Chicago, Illinois 747.2 miles Laura Fearn 312-227-6285 lfearn@luriechildrens.org
Medical College of Wisconsin - Milwaukee, Wisconsin 769.3 miles None None None
University of Florida Jacksonville Shands Medical Center - Jacksonville, Florida 888.5 miles None None None
Arkansas Childrens Hospital - Little Rock, Arkansas 1,128.3 miles Lee Howard 501-364-6990 howardleee@uams.edu
Arkansas Childrens Hospital - Little Rock, Arkansas 1,128.3 miles None None None
Childrens Mercy Hospitals and Clinics - Kansas City, Missouri 1,136.3 miles None None None
Wesely Medical Center - Wichita, Kansas 1,305.6 miles None None None
The Childrens Hospital Colorado - Aurora, Colorado 1,658.2 miles None None None
University of Utah Hospitals and Clinics - Salt Lake City, Utah 2,000.1 miles Sharada Dixit RN 801-587-7525 sharada.dixit@hsc.utah.edu
University of Utah Hospitals and Clinics - Salt Lake City, Utah 2,000.1 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,424.5 miles Megan KeltonRehkopf 206-884-1422 megan.keltonr@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,424.5 miles None None None
University of California at San Diego Medical Center - La Jolla, California 2,471.8 miles None None None
Axis Clinical Trials - Los Angeles, California 2,494.2 miles None None None
University of California Los Angeles Medical Center - Los Angeles, California 2,499.3 miles None None None

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