Summary

Eligibility
for people ages up to 20 years (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion

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 Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity Metformin Interferons Ritonavir Ribavirin Lopinavir Oseltamivir Azithromycin Clindamycin Meropenem Voriconazole Ceftazidime Fosfomycin Cefepime Cefdinir Dexamethasone Budesonide Hydrocortisone 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 up to 20 years

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

You CAN'T join if...

  1. 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)

  1. Has had intermittent dialysis within previous 24 hours
  2. Has had a kidney transplant within previous 30 days
  3. Has had a liver transplant within previous 1 year
  4. Has had a stem cell transplant within previous 1 year
  5. Has had therapeutic hypothermia within previous 24 hours
  6. Has had plasmapheresis within the previous 24 hours
  7. Has a Ventricular Assist Device
  8. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Locations

  • University of California accepting new patients
    Los Angeles California 90095 United States
  • Phoenix Children's Hospital accepting new patients by invitation only
    Phoenix Arizona 85016 United States