Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 20 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  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

Exclusion Criteria

  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)

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Children and young adults who are prescribed drugs of interest Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
  • Drug: 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:
    The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
    Other names:
    • Aminocaproic acid
    • Amiodarone
    • Bosentan
    • Budesonide
    • Cefdinir
    • Cefepime
    • Ceftazidime
    • Clindamycin
    • Clobazam
    • Dexamethasone
    • Dexmedetomidine
    • Dextroamphetamine/Amphetamine
    • Fosfomycin
    • Furosemide
    • Gabapentin
    • Guanfacine
    • Hydrocortisone
    • Labetalol
    • Meropenem
    • Metformin
    • Milrinone
    • Nalbuphine
    • Nicardipine
    • Nifedipine
    • Oseltamivir
    • Oxycodone
    • Risperidone
    • Sertraline
    • Sevelamer Carbonate / Sevelamer Hydrochloride
    • Spironolactone
    • Terbutaline
    • Tranexamic acid
    • Voriconazole
    • Zolpidem
    • Azithromycin
    • Lopinavir/Ritonavir
    • Ribavirin
    • Tocilizumab
    • Anakinra
    • Aspirin
    • Canakinumab
    • Colchicine
    • Interferon
    • Remdesivir
    • Ruxolitinib
    • Sarilumab

Recruiting Locations

Tulane University Health Science Center
New Orleans, Louisiana 70112
Contact:
Amy Katz
504-988-2566
akatz12@tulane.edu

More Details

Status
Recruiting
Sponsor
Duke University

Study Contact

Chi Hornik
(919) 260-7626
chi.hornik@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.