Actively Recruiting

Age: 0Years - 20Years
All Genders
Healthy Volunteers
NCT04278404

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

Led by Duke University · Updated on 2026-04-06

5000

Participants Needed

51

Research Sites

382 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

T

The Emmes Company, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Years - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is under 21 years of age
  • Parent, legal guardian, or adult participant can understand and is willing to provide informed consent and HIPAA authorization
  • Participant is currently receiving one or more of the study drugs prescribed by their provider or has tested positive for SARS-COV-2 within 60 days prior to enrollment
Not Eligible

You will not qualify if you...

  • Participant is known to be pregnant
  • Participant has had intermittent dialysis within the previous 24 hours
  • Participant has had a kidney transplant within the previous 30 days
  • Participant has had a liver transplant within the previous 1 year
  • Participant has had a stem cell transplant within the previous 1 year
  • Participant has undergone therapeutic hypothermia within the previous 24 hours
  • Participant has had plasmapheresis within the previous 24 hours
  • Participant has a Ventricular Assist Device
  • Participant has any condition that makes them unsuitable for the study as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 51 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Completed

2

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States, 72202

Actively Recruiting

3

University of California, Los Angeles Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

4

Lucile Packard Children's Hospital

Palo Alto, California, United States, 94304

Actively Recruiting

5

Colorado University Denver

Aurora, Colorado, United States, 80045

Actively Recruiting

6

The Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Completed

7

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States, 19803

Completed

8

University of Florida Jacksonville Shands Medical Center

Jacksonville, Florida, United States, 32209

Actively Recruiting

9

Kapiolani Womens and Childrens Medical Center

Honolulu, Hawaii, United States, 96826

Actively Recruiting

10

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States, 60611

Completed

11

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States, 60614

Actively Recruiting

12

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

Completed

14

University of Kansas Medical Center-JG Kidney Institute

Kansas City, Kansas, United States, 66160

Completed

15

University of Louisville Norton Childrens Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

16

Tulane University Health Science Center

New Orleans, Louisiana, United States, 70112

Completed

17

Ochsner Baptist Clinical Trials Unit

New Orleans, Louisiana, United States, 70115

Actively Recruiting

18

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Completed

19

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Completed

20

Massachusetts General Hospital

Lexington, Massachusetts, United States, 02421

Completed

21

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Completed

22

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

23

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States, 39110

Completed

24

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Completed

25

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68114

Actively Recruiting

26

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Completed

27

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States, 87131

Completed

28

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Completed

29

Duke University Health System

Durham, North Carolina, United States, 27710

Actively Recruiting

30

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Completed

31

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

32

Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

33

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

34

Pennsylvania State University--Hershey Children's Hospital

Hershey, Pennsylvania, United States, 17033

Completed

35

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Completed

36

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

37

University of South Carolina

Columbia, South Carolina, United States, 29208

Completed

38

Avera McKennan Hospital & University Medical Center

Sioux Falls, South Dakota, United States, 57108

Completed

39

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

40

Dell Children's Medical Center of Central Texas

Austin, Texas, United States, 78723

Actively Recruiting

41

University of Texas-Southwestern Medical Center Dallas

Dallas, Texas, United States, 75390

Active, Not Recruiting

42

University of Texas--Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

Completed

43

The Womens Hospital of Texas

Houston, Texas, United States, 77054

Actively Recruiting

44

University of Utah

Salt Lake City, Utah, United States, 84113

Actively Recruiting

45

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

46

West Virginia University Hospital

Morgantown, West Virginia, United States, 26506

Active, Not Recruiting

47

University of Wisconsin

Madison, Wisconsin, United States, 53705

Actively Recruiting

48

University Wisconsin Madison

Madison, Wisconsin, United States, 53705

Completed

49

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

50

The Hospital for Sick Children

Toronto, Ontario, Canada

Actively Recruiting

51

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

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Research Team

C

Chi Hornik

CONTACT

M

Melissa James, MPH, RD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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