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 Sex
- 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
Lucile Packard Children's Hospital
Palo Alto, California 94304
Palo Alto, California 94304
Duke University Health System
Durham, North Carolina 27710
Durham, North Carolina 27710
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
Austin, Texas 78723
More Details
- NCT ID
- NCT04278404
- Status
- Recruiting
- Sponsor
- Duke University