Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Duke University
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: February 4, 2016
Last verified: February 2016
  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
Infection
Hypertension
Pain
Reflux
Edema
Hyperlipidemia
Hypotension
Hypercholesterolemia
Sedation
Anxiolysis
Benzodiazepine Withdrawal
Bipolar Disorder
Autistic Disorder
Schizophrenia
Influenza Treatment or Prophylaxis
Acute Decompensated Heart Failure
Stable Angina
Life-threatening Fungal Infections
Nosocomial Pneumonia
Community Acquired Pneumonia
Acute Bacterial Exacerbation of Chronic Bronchitis
Complicated Skin and Skin Structure Infections
Uncomplicated Skin and Skin Structure Infections
Chronic Bacterial Prostatitis
Complicated Urinary Tract Infections
Acute Pyelonephritis
Uncomplicated Urinary Tract Infections
Inhalational Anthrax (Post-Exposure)
Infantile Hemangioma
Withdrawal
Inflammation
Bacterial Septicemia
Cytomegalovirus Retinitis
Herpes Simplex Virus
Adenovirus
Brain Swelling
Airway Swelling
Adrenal Insufficiency
Anxiety
Nausea
Vomiting
Convulsions
Muscle Spasms
Seizures
Epilepsy
Bartonellosis
Brucellosis
Cholera
Plague
Psittacosis
Q Fever
Relapsing Fever
Rocky Mountain Spotted Fever
Trachoma
Tularemia
Typhus Fever
Bronchospasm
Cardiac Arrest
Hypersensitivity Reaction
Cyanide Poisoning
Acute Bacterial Sinusitis
Bacterial Meningitis
Sepsis
Gastroparesis
Opioid Addiction
Migraines
Headaches
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 Duke University:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 3000
Study Start Date: November 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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
    • Bumetanide
    • Ceftazidime
    • Cidofovir
    • Ciprofloxacin
    • Clindamycin
    • Dexamethasone
    • Diazepam
    • Dopamine
    • Doxycycline
    • Fentanyl
    • Granisetron
    • Hydroxocobalamin
    • Levetiracetam
    • Levofloxacin
    • Meropenem
    • Methadone
    • Methylprednisolone
    • Metoclopramide
    • Midazolam
    • Nicardipine
    • Norepinephrine
    • Olanzapine
    • Oseltamivir
    • Oxycarbazepine
    • Phosphenytoin
    • Pravastatin
    • Quetiapine
    • Risperadone
    • Simvastatin
    • Timolol
    • Topiramate
    • Valproic Acid
    • Vasopressin
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)
Genders Eligible for Study:   Both
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

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Lee Howard    501-364-6990    howardleee@uams.edu   
Principal Investigator: Laura James, MD         
United States, California
University of California at San Diego Medical Center Recruiting
La Jolla, California, United States, 92093
Contact: Baharin Abdullah    858-246-0012    baabdullah@ucsd.edu   
Principal Investigator: Adriana Tremoulet, MD         
Axis Clinical Trials Terminated
Los Angeles, California, United States, 90036
University of California, Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jaime Deville    310-825-9660    jdeville@mednet.ucla.edu   
Principal Investigator: Jaime Deville, MD         
United States, Colorado
The Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Matthew Steinbess    720-777-3019    matthew.steinbess@childrenscolorado.org   
Contact: Jendar Deschenes       jendar.deschenes@childrenscolorado.org   
Principal Investigator: Peter Mourani, MD         
United States, Connecticut
Yale New Haven Children's Hospital Recruiting
New Haven, Connecticut, United States, 06504
Contact: Elaine Romano    203-688-2320    elaine.romano@yale.edu   
Principal Investigator: Matthew Bizzarro, MD         
United States, Delaware
Alfred I. DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Kimberly Klipner    302-651-4088    kimberly.klipner@nemours.org   
Contact: Ramany John       ramany.john@nemours.org   
Principal Investigator: Marisa Meyer, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Elaine Williams    202-476-2245    efwillia@cnmc.org   
Principal Investigator: John van den Anker, MD, PhD, FAAP, FCP         
United States, Florida
University of Florida Jacksonville Shands Medical Center Recruiting
Jacksonville, Florida, United States, 32209
Contact: Kathleen Thoma    904-244-3059    kathleen.thoma@jax.ufl.edu   
Principal Investigator: Mobeen Rathore, MD         
United States, Illinois
Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Laura Fearn    312-227-6285    lfearn@luriechildrens.org   
Contact: Rohit Kalra       rkalra@luriechildrens.org   
Principal Investigator: Ram Yogev, MD         
United States, Indiana
Riley Hospital for Children at Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lucy Smiley    317-278-7364    lcsmiley@iu.edu   
Principal Investigator: Scott Denne, MD,         
United States, Kansas
Wesely Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Paula Delmore    316-962-8580    paula.delmore@wesleymc.com   
Principal Investigator: Paula Delmore, MSN         
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Poff    502-629-7545    srpoff01@louisville.edu   
Principal Investigator: Janice Sullivan, MD, FAAP, FCCM, CPI, CIP         
United States, Maryland
University of Maryland Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Children's Hospital of Michigan Terminated
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospitals and Clinics Terminated
Kansas City, Missouri, United States, 64108
United States, North Carolina
UNC Hospital Neonatal-Perinatal Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Janice Bernhardt    919-843-2373    bernhardt@unc.edu   
Principal Investigator: Matthew Laughon, MD, MPH         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Samantha Wrenn    919-681-2554    samantha.wrenn@duke.edu   
Contact: Christie Milleson    919-681-2401    christie.milleson@duke.edu   
Principal Investigator: Kevin Watt, MD         
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Tara Terrell    513-803-3294    Tara.Terrell@cchmc.org   
Contact: Theresa Mottes    513-803-3296    theresa.mottes@cchmc.org   
Principal Investigator: Stuart Goldstein, MD         
Case Western University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ramon Adams    216-844-5112    ramon.adams@uhhospitals.org   
Principal Investigator: David Speicher, MD         
Akron Children's Hospital Recruiting
Cleveland, Ohio, United States, 44313
Contact: Heather Anthony, RN    330-543-0731    hanthony@chmca.org   
Principal Investigator: Martha Blackford, PharmD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201-2701
Contact: Kira Clark    503-418-8112    clarki@ohsu.edu   
Contact: Carrie Farrar    503-494-4233    farrarc@ohsu.edu   
Principal Investigator: Amira Al-Uzri, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Al Sarraf Layla    843-792-5309    alsarral@musc.edu   
Contact: Patricia Infinger    832-792-7857    infinge@musc.edu   
Principal Investigator: Andrew Atz, MD         
United States, Utah
University of Utah Hospitals and Clinics Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Sharada Dixit, RN    801-587-7525    sharada.dixit@hsc.utah.edu   
Contact: Melissa Bolton    801-213-3909    Melissa.Bolton@hsc.utah.edu   
Principal Investigator: Catherine Sherwin, MD         
United States, Virginia
University of Virginia Children's Hospital Terminated
Charlottesville, Virginia, United States, 22908-0386
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Megan Kelton-Rehkopf    206-884-1422    megan.keltonr@seattlechildrens.org   
Contact: Shannon Granilo    206-987-1418    shannon.granilo@seattlechildrens.org   
Principal Investigator: Joseph Flynn, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Shawna Joachim    414-955-2817    sjoachim@mcw.edu   
Contact: Katherine Woods    414-266-5936    kawoods@mcw.edu   
Principal Investigator: Beth Drolet, MD         
Canada, Manitoba
Manitoba Institute of Child Health Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Jeannine Schellenberg    1-204-975-7716    jschellenberg@mich.ca   
Contact: Geert T'Jong, MD    1-204-789-3206    gtjong@mich.ca   
Principal Investigator: Geert T'Jong, MD         
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Barbara Murchison    1-613-737-7600 ext 4133    bmurchison@cheo.on.ca   
Principal Investigator: Roger Zemek, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Maggie Rumantir, MD    1-416-813-7654 ext 309153    maggie.rumantir@sickkids.ca   
Principal Investigator: Yaron Finkelstein, MD         
Canada, Quebec
Hospital Sainte-Justine Recruiting
Montreal, Quebec, Canada, T3T 1C5
Contact: Mariana Dumitrascu    1-514-345-4931 ext 6648    mariana.dumitrascu@recherche-ste-justine.qc.ca   
Contact: Catherine Litalien, MD    1-514-345-4931 ext 2571    catherine.litalien.hsj@ssss.gouv.qc.ca   
Principal Investigator: Catherine Litalien, MD         
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Tel Aviv, Israel, 70300
Contact: Matitiahu Berkovitch, MD    011-972-8-977-9152    mberkovitch@asaf.health.gov.il   
Contact: Elkana Kohn       elkanak@asaf.health.gov.il   
Principal Investigator: Matitiahu Berkovitch, MD         
Schneider Children's Medical Center of Israel Recruiting
Petah Tikva, Israel, 49202
Contact: Florencia Kanelo    011-972-5-2-555-4785    florniasi@clalit.org.il   
Contact: Yehezkel (Hezi) Waisman, MD    011-972-3-925-3661    waisy@clalit.org.il   
Principal Investigator: Yehezkel (Hezi) Waisman, MD         
Singapore
KK Women's and Children's Hospital Pte Ltd Recruiting
Singapore, Singapore, 229899
Contact: Jan Hau Lee, MD    1-65-9699-5200    lee.jan.hau@kkh.com.sg   
Contact: Kathy Liaw    1-65-6394-8939    kathy.liaw.cs@kkh.com.sg   
Principal Investigator: Jan Hau Lee, MD         
United Kingdom
Southampton General Hospital Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Danny Pratt    011-44-0-23-8120-3853    danny.pratt@uhs.nhs.uk   
Contact: Iain Macintosh, MD    011-44-0-23-8120-8328    iain.macintosh@uhs.nhs.uk   
Principal Investigator: Iain Macintosh, MD         
Alder Hey Children's Hospital Not yet recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Contact: Amanda Rees    011-44-151-252-5803    amanda.rees@alderhey.nhs.uk   
Contact: Dan Hawcutt, MD    011-44-151-228-4811 ext 2441    d.hawcutt@liverpool.ac.uk   
Principal Investigator: Dan Hawcutt, MD         
University of Bristol Not yet recruiting
Bristol, United Kingdom, BS8 1TH
Contact: Clare Harrison       clare.harrison@uhbristol.nhs.uk   
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  IND 114369  IND 114531  IND 114892  IND 115226  IND 118329  IND 118358 
Study First Received: August 17, 2011
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
infection
hypertension
pain
opioid addiction
reflux
UTI
bronchitis
cyanide poisoning
cardiac arrest
hypotension
pneumonia
Rocky Mountain Spotted Fever
Q Fever
Anthrax
Cholera
Tularemia
Trachoma
Psittacosis
Plague
Brucellosis
Bartonellosis
hypercholesterolemia
Heterozygous Familial Hypercholesterolemia (HeFH)
Primary Prevention of Coronary Events
Acute pulmonary edema
edema
ADHD
sedation
anxiolysis
benzodiazepine withdrawal

Additional relevant MeSH terms:
Disease
Infection
Communicable Diseases
Hypertension
Heart Failure
Schizophrenia
Inflammation
Pneumonia
Epilepsy
Migraine Disorders
Sepsis
Bipolar Disorder
Hypercholesterolemia
Seizures
Headache
Nausea
Vomiting
Fever
Heart Arrest
Behavior, Addictive
Hypotension
Hyperlipidemias
Mycoses
Sinusitis
Gastroparesis
Urinary Tract Infections
Meningitis
Hypersensitivity
Retinitis
Bronchitis

ClinicalTrials.gov processed this record on December 06, 2016