Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Last updated: March 11, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Pneumonia

Hemophilia

Treatment

The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

Clinical Study ID

NCT04278404
Pro00103838
  • Ages < 20
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant is < 21 years of age

  2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and iswilling to provide informed consent/HIPAA:

  3. (a) Participant is receiving one or more of the study drugs of interest at the timeof enrollment or (b) Participant is NOT receiving one or more of the study drugs ofinterest but is SARS-COV-2 positive within 60 days prior to enrollment

Exclusion

Exclusion Criteria:

  1. Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of interest at the time ofenrollment, DOI administration or PK sampling: (Refer to DOI specific appendices fordetails on enrollment cohort specifications and additional eligibility criteria)

  2. Has had intermittent dialysis within previous 24 hours

  3. Has had a kidney transplant within previous 30 days

  4. Has had a liver transplant within previous 1 year

  5. Has had a stem cell transplant within previous 1 year

  6. Has had therapeutic hypothermia within previous 24 hours

  7. Has had plasmapheresis within the previous 24 hours

  8. Has a Ventricular Assist Device

  9. Has any condition which would make the participant, in the opinion of theinvestigator, unsuitable for the study

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Phase:
Study Start date:
March 05, 2020
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario
    Canada

    Active - Recruiting

  • CHU Sainte-Justine

    Montréal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • University of California

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California, Los Angeles Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Lucile Packard Children's Hospital

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Colorado University Denver

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • The Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Alfred I. DuPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Completed

  • University of Florida Jacksonville Shands Medical Center

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Kapiolani Womens and Childrens Medical Center

    Honolulu, Hawaii 96826
    United States

    Active - Recruiting

  • Ann and Robert H. Lurie Childrens Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Riley Hospital for Children at Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Iowa Stead Family Children's Hospital

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Terminated

  • University of Kansas Medical Center-JG Kidney Institute

    Kansas City, Kansas 66160
    United States

    Completed

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Louisville Norton Childrens Hospital

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Ochsner Baptist Clinical Trials Unit

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Tulane Pediatrics

    New Orleans, Louisiana 70001
    United States

    Terminated

  • Tulane University Health Science Center

    New Orleans, Louisiana 70112
    United States

    Completed

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Completed

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Lexington, Massachusetts 02421
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Completed

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi 39110
    United States

    Completed

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Completed

  • Childrens Mercy Hospital

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Completed

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico 87131
    United States

    Completed

  • Kravis Children's Hospital at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • New Hanover Regional Medical Center

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Board of Regents of the University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Pennsylvania State University--Hershey Children's Hospital

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Completed

  • Medical University of South Carolina Children's Hospital

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • University of South Carolina

    Columbia, South Carolina 29208
    United States

    Completed

  • Avera McKennan Hospital & University Medical Center

    Sioux Falls, South Dakota 57108
    United States

    Completed

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas 78723
    United States

    Active - Recruiting

  • University of Texas-Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas-Southwestern Medical Center Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • The Womens Hospital of Texas

    Houston, Texas 77054
    United States

    Active - Recruiting

  • University of Texas--Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University Wisconsin

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • University Wisconsin Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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