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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    5000
  • sponsor
    Duke University
Updated on 25 January 2021
SARS

Summary

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.

Details
Condition Coronavirus Infection, Pulmonary Disease, Adrenal Insufficiency, Arrhythmia, Edema, Down Syndrome, Coagulopathy, Oppositional Defiant Disorder, Vascular Diseases, Attention deficit hyperactivity disorder, Hyperphosphatemia, Heart failure, Heart disease, Insomnia, Upper respiratory infection, Hypokalemia, Kawasaki Disease, Bronchopulmonary Dysplasia, Hypertension, Hemophilia A, Pneumonia, Hyperaldosteronism, skin infection, Cellulitis, Menorrhagia, Hypomenorrhea, Pain, Acute Pain Service, Coronavirus, Skin Infections/Disorders, Diabetes and Hypertension, Throat and Tonsil Infections, High Blood Pressure (Hypertension), Attention Deficit/Hyperactivity Disorder (ADHD - Adults), Attention Deficit/Hyperactivity Disorder (ADHD - Pediatric), High Blood Pressure (Hypertension - Pediatric), Post-Surgical Pain, Pulmonary Arterial Hypertension, Hypertension Resistant to Conventional Therapy, Childhood Asthma, Asthma in Children, Pain (Pediatric), Oppositional Defiant Disorder (ODD), Pneumonia (Pediatric), Elevated Blood Pressure, Urinary Tract Infections in Children, Family Medicine-ADHD Pediatrics, Congestive Heart Failure, Lung Disease, Menstrual Disorders, Hemophilia, Down's Syndrome, Dysrhythmia, Cardiac Disease, Hemophilia Prior to Tooth Extraction, Fibrinolysis; Hemorrhage, Fibrinolysis; Hemorrhage, Fibrinolysis; Hemorrhage, Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C), Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C), Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C), Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C), primary hyperaldosteronism, skin infections, pneumoniae, pneumonitis, lung inflammation, bronchopulmonary dysplasia (bpd), ache, swelling, oedema, hypoadrenalism, adhd, primary aldosteronism, conn, hema, trisomy 21, high blood pressure, arterial hypertension, clotting, bleeding diathesis, bleeding tendency, blood coagulation disorders, coagulopathies, bleeding disorders, coagulation disorder, bleeding disorder, clotting disorders, blood clotting disorders, cardiac failure, cardiac arrhythmia, cardiac dysrhythmias, arrhythmias, cardiac arrhythmias, dysrhythmias, abnormal heart rhythms, adrenal cortical insufficiency, congestive heart disease, Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C)
Treatment The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Clinical Study IdentifierNCT04278404
SponsorDuke University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant is < 21 years of age and
is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR
is NOT receiving one or more of the study drugs of interest but is SARS-CoV-2 positive within 60 days prior to enrollment
Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA

Exclusion Criteria

Participant has a known pregnancy
For 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)
\. 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 the
investigator, unsuitable for the study
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