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

a study on COVID-19 High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension Urinary Tract Infection Pain Hyperphosphatemia Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia Insomnia Sleep Disorders Pneumonia Skin Infection Arrythmia Asthma Bronchopulmonary Dysplasia Dysplasia Adrenal Insufficiency Attention-Deficit/Hyperactivity Disorder Multisystem Inflammatory Syndrome in Adults Multisystem Inflammatory Syndrome in Children Kawasaki Disease Coagulation Disorder Down Syndrome Blood Coagulation Disorder Amphetamines

Summary

Eligibility
for people ages 0-20 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Jaime Deville

Description

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.

Official Title

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Keywords

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, Infections, Communicable Diseases, Coronavirus Infections, Urinary Tract Infections, Hemostatic Disorders, Mucocutaneous Lymph Node Syndrome, Blood Coagulation Disorders, Hyperaldosteronism, Syndrome, Hemorrhage, Attention Deficit Disorder with Hyperactivity, Metformin, Interferons, Ritonavir, Ribavirin, Lopinavir, Oseltamivir, Remdesivir, Azithromycin, Clindamycin, Meropenem, Voriconazole, Ceftazidime, Fosfomycin, Cefepime, Cefdinir, Dexamethasone, Budesonide, Hydrocortisone, Infliximab, Abatacept, Colchicine, Amiodarone, Bosentan, Guanfacine, Labetalol, Nicardipine, Nifedipine, Milrinone, Furosemide, Spironolactone, Dexmedetomidine, Oxycodone, Gabapentin, Nalbuphine, Clobazam, Zolpidem, Risperidone, Amphetamine, Dextroamphetamine, Sertraline, Tranexamic Acid, Aminocaproic Acid, Terbutaline, Sevelamer

Eligibility

You can join if…

Open to people ages 0-20

  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

You CAN'T join if...

  1. 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

Locations

  • University of California, Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Lucile Packard Children's Hospital accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at UCLA

  • Jaime Deville
    HS Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 56 research publications