Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)

Duke University

Status: Enrolling

Conditions: Hypokalemia; Adrenal Insufficiency; Primary Hyperaldosteronism; Down Syndrome; Insomnia; Multisystem Inflammatory Syndrome in Children (MIS-C); Arrythmia; Fibrinolysis; Hemorrhage; Asthma in Children; Kawasaki Disease; Pneumonia; Hyperphosphatemia; Menorrhagia; Pain; Attention Deficit Hyperactivity Disorder; Coagulation Disorder; Bronchopulmonary Dysplasia; Heart Failure; Coronavirus Infection (COVID-19); Pulmonary Arterial Hypertension; Edema; Urinary Tract Infections in Children; Hypertension; Skin Infection; Hemophilia

Treatments: 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:

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT04278404

Pro00103838

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

5,000 participants in 1 patient group

Children and young adults who are prescribed drugs of interest

Description:

Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.

Treatment:

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: