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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

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

Condition
Coronavirus Infection (COVID-19)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States, 72202

Los Angeles

University of California, Los Angeles Medical Center, Los Angeles, California, United States, 90095

Palo Alto

Lucile Packard Children's Hospital, Palo Alto, California, United States, 94304

Aurora

Colorado University Denver, Aurora, Colorado, United States, 80045

Aurora

The Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Wilmington

Alfred I. DuPont Hospital for Children, Wilmington, Delaware, United States, 19803

Jacksonville

University of Florida Jacksonville Shands Medical Center, Jacksonville, Florida, United States, 32209

Honolulu

Kapiolani Womens and Childrens Medical Center, Honolulu, Hawaii, United States, 96826

Chicago

Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States, 60611

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Participant has a known pregnancy
  • 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

Ages Eligible for Study

0 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Chi Hornik, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

2027-09