RecruitingNCT04278404

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

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Sponsor

Duke University

Enrollment

5,000 participants

Start Date

Mar 5, 2020

Study Type

OBSERVATIONAL

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

Min Age: 0 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study collects information about how medications behave in children and teenagers — including how the body processes them, their effects, and their safety. It focuses on drugs that are commonly used in children but haven't been well-studied in younger patients, including some used in COVID-19 treatment. **You may be eligible if...** - You are under 21 years old - You are currently receiving one of the study's medications as part of your regular care, OR - You tested positive for COVID-19 within the past 60 days - A parent or guardian can provide informed consent **You may NOT be eligible if...** - You are pregnant - There are other specific medical conditions that disqualify participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThe 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:

The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.

Locations(51)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

University of California, Los Angeles Medical Center

Los Angeles, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Colorado University Denver

Aurora, Colorado, United States

The Children's Hospital Colorado

Aurora, Colorado, United States

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

University of Florida Jacksonville Shands Medical Center

Jacksonville, Florida, United States

Kapiolani Womens and Childrens Medical Center

Honolulu, Hawaii, United States

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, United States

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States

University of Kansas Medical Center-JG Kidney Institute

Kansas City, Kansas, United States

University of Louisville Norton Childrens Hospital

Louisville, Kentucky, United States

Tulane University Health Science Center

New Orleans, Louisiana, United States

Ochsner Baptist Clinical Trials Unit

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Lexington, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Health System

Durham, North Carolina, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Pennsylvania State University--Hershey Children's Hospital

Hershey, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, United States

University of South Carolina

Columbia, South Carolina, United States

Avera McKennan Hospital & University Medical Center

Sioux Falls, South Dakota, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

University of Texas-Southwestern Medical Center Dallas

Dallas, Texas, United States

University of Texas--Memorial Hermann Texas Medical Center

Houston, Texas, United States

The Womens Hospital of Texas

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

University Wisconsin Madison

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

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