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NCT04278404RecruitingAccepts Healthy Volunteers

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

Duke University

Start Date

3/5/2020

Completion Date

7/1/2027

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

Age Range: No minimum to 20 years

Inclusion Criteria: 1. Participant is \< 21 years of age 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA: 3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment 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 of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details 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 the investigator, unsuitable for the study

Interventions

DRUG

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:

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Conditions

Coronavirus Infection (COVID-19)Pulmonary Arterial HypertensionUrinary Tract Infections in ChildrenHypertensionPainHyperphosphatemiaPrimary HyperaldosteronismEdemaHypokalemiaHeart FailureHemophiliaMenorrhagiaInsomniaPneumoniaSkin InfectionArrythmiaAsthma in ChildrenBronchopulmonary DysplasiaAdrenal InsufficiencyFibrinolysis; HemorrhageAttention Deficit Hyperactivity DisorderMultisystem Inflammatory Syndrome in Children (MIS-C)Kawasaki DiseaseCoagulation DisorderDown Syndrome

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas 72202

United States

University of California, Los Angeles Medical Center

Los Angeles, California 90095

United States

Lucile Packard Children's Hospital

Palo Alto, California 94304

United States

Colorado University Denver

Aurora, Colorado 80045

United States

The Children's Hospital Colorado

Aurora, Colorado 80045

United States

Alfred I. DuPont Hospital for Children

Wilmington, Delaware 19803

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

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois 60611

United States

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois 60614

United States

Riley Hospital for Children at Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa 52242

United States

University of Kansas Medical Center-JG Kidney Institute

Kansas City, Kansas 66160

United States

University of Louisville Norton Childrens 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

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Massachusetts General Hospital

Lexington, Massachusetts 02421

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Mississippi Center for Advanced Medicine

Madison, Mississippi 39110

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

University of Nebraska Medical Center

Omaha, Nebraska 68114

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

University of New Mexico Health Science Center

Albuquerque, New Mexico 87131

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University Health System

Durham, North Carolina 27710

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio 45229

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio 45229

United States

Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Pennsylvania State University--Hershey Children's Hospital

Hershey, Pennsylvania 17033

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Medical University of South Carolina Children's Hospital

Charleston, South Carolina 29425

United States

University of South Carolina

Columbia, South Carolina 29208

United States

Avera McKennan Hospital & University Medical Center

Sioux Falls, South Dakota 57108

United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Dell Children's Medical Center of Central Texas

Austin, Texas 78723

United States

University of Texas-Southwestern Medical Center Dallas

Dallas, Texas 75390

United States

University of Texas--Memorial Hermann Texas Medical Center

Houston, Texas 77030

United States

The Womens Hospital of Texas

Houston, Texas 77054

United States

University of Utah

Salt Lake City, Utah 84113

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

West Virginia University Hospital

Morgantown, West Virginia 26506

United States

University of Wisconsin

Madison, Wisconsin 53705

United States

University Wisconsin Madison

Madison, Wisconsin 53705

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

The Hospital for Sick Children

Toronto, Ontario

Canada

CHU Sainte-Justine

Montreal, Quebec H3T 1C5

Canada