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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278404
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment
Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Prior to Tooth Extraction Menorrhagia Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Hypertension, Resistant to Conventional Therapy Fibrinolysis; Hemorrhage 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:

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : April 24, 2024
Estimated Study Completion Date : April 24, 2024


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.
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- Immediate Release
  • 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
  • Dextroamphetamine /Amphetamine - Extended Release
  • Azithromycin
  • Chloroquine
  • Hydroxychloroquine
  • Lopinavir/Ritonavir
  • Ribavirin
  • Tocilizumab




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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. ]
  8. 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. ]

Biospecimen Retention:   Samples With DNA
Whole blood, effluent samples, and plasma.


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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children under 21 years of age.
Criteria

Inclusion Criteria:

  1. 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
  2. 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

    Participant 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278404


Contacts
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Contact: Chi Hornik (919) 260-7626 chi.hornik@duke.edu
Contact: Jerry Kirchner (919) 812-1798 jerry.kirchner@duke.edu

Locations
Show Show 35 study locations
Sponsors and Collaborators
Duke University
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Chi Hornik Duke Clinical Research Institute
Additional Information:
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04278404    
Other Study ID Numbers: Pro00103838
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Coronavirus Infections
Severe Acute Respiratory Syndrome
Bronchopulmonary Dysplasia
Menorrhagia
Hypertension
Hyperphosphatemia
Hypokalemia
Adrenal Insufficiency
Hyperaldosteronism
Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Urologic Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases