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

  • STATUS
    Recruiting
  • participants needed
    5000
  • sponsor
    Duke University
Updated on 19 February 2024
SARS
acute respiratory syndrome (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, Arrhythmia, Edema, Down Syndrome, Coagulopathy, Oppositional Defiant Disorder, Vascular Diseases, Vascular Diseases, Attention deficit hyperactivity disorder, Hyperphosphatemia, Heart failure, Heart failure, Heart disease, Heart disease, Insomnia, Insomnia, Upper respiratory infection, Hypokalemia, Kawasaki Disease, Kawasaki Disease, Bronchopulmonary Dysplasia, Hypertension, Hemophilia A, Pneumonia, Pneumonia, Hyperaldosteronism, skin infection, Menorrhagia, Hypomenorrhea, Pain, Pain, Acute Pain Service, Asthma in Children, Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Fibrinolysis; Hemorrhage, Multisystem Inflammatory Syndrome in Children (MIS-C)
Age 20 years and younger
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 on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

(a) 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 (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
\. 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
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

site

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

Loading...

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 • 

 • 

Private

Reply by • Private
Loading...

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.
Loading...

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