Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Purpose
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
Eligibility
- Eligible Ages
- Between 0 Years and 20 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Children and young adults who are prescribed drugs of interest | Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive. |
|
Recruiting Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
Phoenix, Arizona 85016
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
University of California, Los Angeles Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
Lucile Packard Children's Hospital
Palo Alto, California 94304
Palo Alto, California 94304
Colorado University Denver
Aurora, Colorado 80045
Aurora, Colorado 80045
The Children's Hospital Colorado
Aurora, Colorado 80045
Aurora, Colorado 80045
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Kapiolani Womens and Childrens Medical Center
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois 60611
Chicago, Illinois 60611
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois 60614
Chicago, Illinois 60614
Riley Hospital for Children at Indiana University
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Louisville Norton Childrens Hospital
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Massachusetts General Hospital
Lexington, Massachusetts 02421
Lexington, Massachusetts 02421
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Mississippi Center for Advanced Medicine
Madison, Mississippi 39110
Madison, Mississippi 39110
University of Nebraska Medical Center
Omaha, Nebraska 68114
Omaha, Nebraska 68114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Health System
Durham, North Carolina 27710
Durham, North Carolina 27710
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
Pennsylvania State University--Hershey Children's Hospital
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Medical University of South Carolina Children's Hospital
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
Austin, Texas 78723
University of Texas--Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
The Womens Hospital of Texas
Houston, Texas 77054
Houston, Texas 77054
University of Utah
Salt Lake City, Utah 84113
Salt Lake City, Utah 84113
Seattle Children's Hospital
Seattle, Washington 98105
Seattle, Washington 98105
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT04278404
- Status
- Recruiting
- Sponsor
- Duke University