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

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


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.

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


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
\. 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note