RECRUITING

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

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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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Quick Facts

Study Start:2020-03-05
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04278404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant is \< 21 years of age
  2. 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
  3. 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
  1. 1. Participant has a known pregnancy
  2. 2. Has had intermittent dialysis within previous 24 hours
  3. 3. Has had a kidney transplant within previous 30 days
  4. 4. Has had a liver transplant within previous 1 year
  5. 5. Has had a stem cell transplant within previous 1 year
  6. 6. Has had therapeutic hypothermia within previous 24 hours
  7. 7. Has had plasmapheresis within the previous 24 hours
  8. 8. Has a Ventricular Assist Device
  9. 9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Contacts and Locations

Study Contact

Chi Hornik
CONTACT
(919) 260-7626
chi.hornik@duke.edu
Jerry Kirchner
CONTACT
(919) 812-1798
jerry.kirchner@duke.edu

Principal Investigator

Chi Hornik
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute

Study Locations (Sites)

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
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

Collaborators and Investigators

Sponsor: Duke University

  • Chi Hornik, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-05
Study Completion Date2027-09

Study Record Updates

Study Start Date2020-03-05
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Coronavirus Infection (COVID-19)
  • Pulmonary Arterial Hypertension
  • Urinary Tract Infections in Children
  • Hypertension
  • Pain
  • Hyperphosphatemia
  • Primary Hyperaldosteronism
  • Edema
  • Hypokalemia
  • Heart Failure
  • Hemophilia
  • Menorrhagia
  • Insomnia
  • Pneumonia
  • Skin Infection
  • Arrythmia
  • Asthma in Children
  • Bronchopulmonary Dysplasia
  • Adrenal Insufficiency
  • Fibrinolysis; Hemorrhage
  • Attention Deficit Hyperactivity Disorder
  • Multisystem Inflammatory Syndrome in Children (MIS-C)
  • Kawasaki Disease
  • Coagulation Disorder
  • Down Syndrome