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

March 31, 2026 updated by: Duke University

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Completed
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura James
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaime Deville
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eunice Koh
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Aurora, Colorado, United States, 80045
        • Completed
        • The Children's Hospital Colorado
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Completed
        • Alfred I. DuPont Hospital for Children
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Jacksonville Shands Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mobeen Rathore
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Recruiting
        • Ann and Robert H. Lurie Childrens Hospital of Chicago
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Muller
      • Chicago, Illinois, United States, 60611
        • Completed
        • Ann and Robert H. Lurie Childrens Hospital of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children at Indiana University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Thomas
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • University of Iowa Stead Family Children's Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • University of Kansas Medical Center-JG Kidney Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner Baptist Clinical Trials Unit
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda England
      • New Orleans, Louisiana, United States, 70112
        • Completed
        • Tulane University Health Science Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Completed
        • Boston Children's Hospital
      • Lexington, Massachusetts, United States, 02421
        • Completed
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Completed
        • University of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Majure
      • Madison, Mississippi, United States, 39110
        • Completed
        • Mississippi Center for Advanced Medicine
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Completed
        • Children's Mercy Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Russell McCulloh
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Completed
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Completed
        • University of New Mexico Health Science Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Completed
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stuart Goldstein
      • Cincinnati, Ohio, United States, 45229
        • Completed
        • Cincinnati Childrens Hospital Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Board of Regents of the University of Oklahoma
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helen Allen
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Serena Kelly
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Completed
        • Pennsylvania State University--Hershey Children's Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Completed
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Atz
      • Columbia, South Carolina, United States, 29208
        • Completed
        • University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Completed
        • Avera McKennan Hospital & University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
        • Contact:
        • Principal Investigator:
          • Jorn-Hendrik Weitkamp
    • Texas
      • Austin, Texas, United States, 78723
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • University of Texas-Southwestern Medical Center Dallas
      • Houston, Texas, United States, 77054
      • Houston, Texas, United States, 77030
        • Completed
        • University of Texas--Memorial Hermann Texas Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • University of Utah
        • Contact:
        • Contact:
        • Principal Investigator:
          • Danielle Green
        • Sub-Investigator:
          • Jill Sweney
    • Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Awni Al-Subu
      • Madison, Wisconsin, United States, 53705
        • Completed
        • University Wisconsin Madison
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nathan Thompson
        • Sub-Investigator:
          • Michael Meyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children under 21 years of age.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • Sertraline
  • Dexamethasone
  • Hydrocortisone
  • Budesonide
  • Aspirin
  • Sarilumab
  • Metformin
  • Dexmedetomidine
  • Oseltamivir
  • Ribavirin
  • Nicardipine
  • Clonidine
  • Nifedipine
  • Risperidone
  • Ruxolitinib
  • Albuterol
  • Colchicine
  • Aminocaproic acid
  • Amiodarone
  • Bosentan
  • Cefdinir
  • Cefepime
  • Ceftazidime
  • Clindamycin
  • Clobazam
  • Dextroamphetamine/Amphetamine
  • Fosfomycin
  • Furosemide
  • Gabapentin
  • Guanfacine
  • Labetalol
  • Meropenem
  • Milrinone
  • Nalbuphine
  • Oxycodone
  • Sevelamer Carbonate / Sevelamer Hydrochloride
  • Spironolactone
  • Terbutaline
  • Tranexamic acid
  • Voriconazole
  • Zolpidem
  • Azithromycin
  • Lopinavir/Ritonavir
  • Tocilizumab
  • Anakinra
  • Canakinumab
  • Interferon
  • Remdesivir
  • Abatacept
  • Infliximab
  • Dapagliflozin
  • Fluticasone
  • Hydrochlorothiazide
  • Valganciclovir
  • Cephalexin
  • Hydralazine
  • Beclomethasone
  • Ganciclovir
  • Bivalirudin
  • Bumetanide
  • Chlorothiazide
  • Diazoxide
  • Drug-Drug Interaction Combinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Elimination rate constant (ke) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Half-life (t1/2) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Absorption rate constant (ka) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
AUC (area under the curve) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Maximum concentration (Cmax) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Time to achieve maximum concentration (Tmax) as measured by PK sampling
Time Frame: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC

Investigators

  • Principal Investigator: Chi Hornik, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00103838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on 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:

  • Children's Hospital Medical Center, Cincinnati
    Recruiting
    Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
    Lymphoma | Follicular Lymphoma | Leukemia | B Cell Lymphoma | Hodgkin Lymphoma | Burkitt Lymphoma | AML | Non Hodgkin Lymphoma | Acute Lymphocytic Leukemia | Acute Myelogenous Leukemia | Diffuse Large B Cell Lymphoma | Hematologic Malignancy | Chronic Myelogenous Leukemia | Myeloproliferative Neoplasm | T-cell Lymphoma | Peripheral T Cell Lymphoma and other conditions
    United States
  • Duke University
    Food and Drug Administration (FDA)
    Recruiting
    Opportunistic PK/PD Trial in Critically Ill Children (OPTIC) (OPTIC)
    Critically Ill | Cardiac Disease | Children, Adult
    United States
  • Daniel Benjamin
    Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaborators
    Completed
    Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)
    Heart Failure | Epilepsy | Pain | Pneumonia | Sepsis | Inflammation | Hypertension | Chronic Kidney Diseases | Hemophilia | Schizophrenia | Central Nervous System Infections | Nosocomial Pneumonia | Insomnia | Anxiety | Bipolar Disorder | Neutropenia | Staphylococcal Infections | Bradycardia | Seizures | Urinary Tract Infections | Pulmonary... and other conditions
    United States, Canada, United Kingdom, Israel, Singapore

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