Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
G
Gregory Sokol, MD
Primary Investigator
Enrolling By Invitation
20 years and younger
All
Phase
N/A
5000 participants needed
1 Location
Brief description of study
The study investigators are interested in learning more about how drugs, that are given tohildren 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 thisudy is to evaluate the PK of understudied drugs currently being administered to childrenC as prescribed by their treating provider.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Riley, 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
-
Age: - 20 Years
-
Gender: All
Inclusion Criteria:
- Participant is < 21 years of age
- Parent/ Legal Guardian/ Adult Participant can understand the consent process and iswilling to provide informed consent/HIPAA:
- (a) Participant is receiving one or more of the study drugs of interest at the time of(b) Participant is NOT receiving one or more of the study drugs ofbut is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
- Participant has a known pregnancy Below exclusion criteria apply only to participantsving one or more of the study drugs of interest at the time of enrollment,
- Has had intermittent dialysis within previous 24 hours
- Has had a kidney transplant within previous 30 days
- Has had a liver transplant within previous 1 year
- Has had a stem cell transplant within previous 1 year
- Has had therapeutic hypothermia within previous 24 hours
- Has had plasmapheresis within the previous 24 hours
- Has a Ventricular Assist Device
- Has any condition which would make the participant, in the opinion of thevestigator, unsuitable for the study
Updated on
14 Sep 2024.
Study ID: Pro00103838, PNEO-DUKE-POPS02, 2004515305
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