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Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Daniel Benjamin, Duke University Medical Center
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
OpAns, LLC
Information provided by (Responsible Party):
Daniel Benjamin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01431326
First received: August 17, 2011
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 3000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Condition Intervention
Adenovirus Adrenal Insufficiency Airway Swelling Anesthesia Anxiety Anxiolysis Autism Autistic Disorder Bacterial Meningitis Bacterial Septicemia Benzodiazepine Bipolar Disorder Bone and Joint Infections Brain Swelling Central Nervous System Infections Convulsions Cytomegalovirus Retinitis Early-onset Schizophrenia Spectrum Disorders Edema Epilepsy General Anesthesia Gynecologic Infections Headaches Herpes Simplex Virus Hypertension Infantile Hemangioma Infection Inflammation Inflammatory Conditions Influenza Intra-abdominal Infections Lower Respiratory Tract Infections Migraines Pain Pneumonia Prophylaxis Schizophrenia Sedation Seizures Skeletal Muscle Spasms Skin and Skin-structure Infections Stable Angina Thromboprophylaxis Thrombosis Treatment-resistant Schizophrenia Urinary Tract Infection Withdrawal Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Resource links provided by NLM:


Further study details as provided by Daniel Benjamin, Duke University Medical Center:

Primary Outcome Measures:
  • Composite of pharmacokinetic outcomes for understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]

    As appropriate for each study drug, the following additional PK parameters will be estimated:

    • maximum concentration (Cmax)
    • time to achieve maximum concentration (Tmax)
    • absorption rate constant (ka)
    • elimination rate constant (kel)
    • half-life (t1/2)
    • area under the curve (AUC)

    Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.



Secondary Outcome Measures:
  • Composite pharmacodynamic outcomes of understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
    When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations.

  • Biomarkers associated with understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
    The dosing, sampling, and demographic information recorded on the eCRF will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed.


Biospecimen Retention:   Samples With DNA
whole blood

Estimated Enrollment: 10000
Study Start Date: November 2011
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
    Other Names:
    • aripiprazole
    • ceftazidime
    • cidofovir
    • ciprofloxacin
    • dexamethasone
    • diazepam
    • levetiracetam
    • meropenem
    • methylprednisolone
    • midazolam
    • nicardipine
    • olanzapine
    • oseltamivir
    • oxycarbazepine
    • phosphenytoin
    • quetiapine
    • risperidone
    • timolol
    • topiramate
    • valproic acid
    • tobramycin
    • alfentanil
    • clozapine
    • fosphenytoin
    • haloperidol
    • heparin (low molecular weight)
    • hydromorphone
    • lurasidone
    • molindone
    • morphine
    • pentobarbital
    • propofol
    • warfarin (oral)
    • ziprasidone
Detailed Description:

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on therapeutic exposure.

Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic profiles will impact drug exposure in children.

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Criteria

Inclusion Criteria:

  • 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

  • 1) Failure to obtain consent/assent (as indicated)
  • 2) Known pregnancy as determined via interview or testing if available.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431326

Contacts
Contact: Chiara Melloni, MD 919-668-8646 chiara.melloni@dm.duke.edu
Contact: Barrie L Harper, MT (ASCP) 919-668-8291 barrie.harper@duke.edu

  Show 37 Study Locations
Sponsors and Collaborators
Daniel Benjamin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
OpAns, LLC
Investigators
Principal Investigator: Michael Cohen-Wolkowiez, MD Duke University
Study Chair: Chiara Melloni, MD Duke University
  More Information

Additional Information:
Publications:

Responsible Party: Daniel Benjamin, Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01431326     History of Changes
Other Study ID Numbers: Pro00029638
IND 113645 ( Other Identifier: FDA )
IND 114369 ( Other Identifier: FDA )
IND 114531 ( Other Identifier: FDA )
IND 114892 ( Other Identifier: FDA )
IND 115226 ( Other Identifier: FDA )
IND 118329 ( Other Identifier: FDA )
IND 118358 ( Other Identifier: FDA )
HHSN20100006 ( Other Grant/Funding Number: NICHD )
HHSN27500020 ( Other Grant/Funding Number: NICHD )
HHSN27500027 ( Other Grant/Funding Number: NICHD )
HHSN27500043 ( Other Grant/Funding Number: NICHD )
Study First Received: August 17, 2011
Last Updated: March 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Completed study datasets (limited PHI) may be requested from https://pediatrictrials.org/data-sharing-opportunities

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Benjamin, Duke University Medical Center:
adenovirus
adrenal insufficiency
afterload inducer
amnestic
anaesthetic
anesthesia
angina
anticoagulant
anti-epileptic
anti-inflammatory
antimicrobial
anti-psychotic
antiviral
anxiety
anxiolysis
anxiolytic
autism
autistic disorder
benzodiazepine
bipolar disorder
convulsions
edema
epilepsy
headaches
herpes simplex virus
HSV
hypertension
infantile hemangioma
infection
inflammation

Additional relevant MeSH terms:
Disease
Infection
Communicable Diseases
Hypertension
Schizophrenia
Inflammation
Pneumonia
Epilepsy
Migraine Disorders
Bipolar Disorder
Thrombosis
Headache
Seizures
Urinary Tract Infections
Meningitis
Respiratory Tract Infections
Retinitis
Adenoviridae Infections
Angina, Stable
Herpes Simplex
Autistic Disorder
Hemangioma
Intraabdominal Infections
Adrenal Insufficiency
Cytomegalovirus Retinitis
Hemangioma, Capillary
Port-Wine Stain
Sepsis
Toxemia
Meningitis, Bacterial

ClinicalTrials.gov processed this record on September 19, 2017