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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01431326
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Information provided by (Responsible Party):
Daniel Benjamin, Duke University

Brief Summary:
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 7000 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 or disease Intervention/treatment
Adenovirus Anesthesia Anxiety Anxiolysis Autism Autistic Disorder Bacterial Meningitis Bacterial Septicemia Benzodiazepine Bipolar Disorder Bone and Joint Infections Central Nervous System Infections Convulsions Cytomegalovirus Retinitis Early-onset Schizophrenia Spectrum Disorders Epilepsy General Anesthesia Gynecologic Infections Herpes Simplex Virus Infantile Hemangioma Infection Inflammation Inflammatory Conditions Intra-abdominal Infections Lower Respiratory Tract Infections Migraines Pain Pneumonia Schizophrenia Sedation Seizures Skeletal Muscle Spasms Skin and Skin-structure Infections Treatment-resistant Schizophrenia Urinary Tract Infections Withdrawal Sepsis Gram-negative Infection Bradycardia Cardiac Arrest Cardiac Arrhythmia Staphylococcal Infections Nosocomial Pneumonia Neuromuscular Blockade Methicillin Resistant Staphylococcus Aureus Endocarditis Neutropenia Headache Fibrinolytic Bleeding Pulmonary Arterial Hypertension CMV Retinitis Hypertension Chronic Kidney Diseases Hyperaldosteronism Hypokalemia Heart Failure Hemophilia Heavy Menstrual Bleeding Insomnia Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

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.

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Study Type : Observational
Actual Enrollment : 3520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Actual Study Start Date : November 2011
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019



Intervention Details:
  • Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
    Other Names:
    • cidofovir
    • ciprofloxacin
    • methylprednisolone
    • tobramycin
    • alfentanil
    • clozapine
    • haloperidol
    • lurasidone
    • molindone
    • pentobarbital
    • warfarin (oral)
    • ziprasidone
    • amikacin
    • cefepime
    • nafcillin
    • piperacillin-tazobactam
    • rocuronium
    • vecuronium
    • vancomycin
    • aminocaproic acid
    • bosentan
    • fosfomycin
    • labetalol
    • nifedipine
    • oxycodone
    • sevelamer carbonate
    • spironolactone
    • tranexamic acid
    • zolpidem


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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 electronic data collection forms 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


Information from the National Library of Medicine

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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.

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): NCT01431326


Locations
Hide Hide 52 study locations
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United States, Alaska
Alaska Native Medical Center
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
University of California at San Diego Medical Center
La Jolla, California, United States, 92093
Axis Clinical Trials
Los Angeles, California, United States, 90036
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06504
United States, Delaware
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida, United States, 32209
United States, Hawaii
Kapiolani Womens and Childrens Medical Center
Honolulu, Hawaii, United States, 96826
United States, Illinois
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
United States, Indiana
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
Children's Mercy Hospital and Clinics
Kansas City, Kansas, United States, 66160
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Science Center
New Orleans, Louisiana, United States, 70112
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States, 70115-6969
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, Montana
University of Montana
Missoula, Montana, United States, 59804
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
UNC Hospital Neonatal-Perinatal Medicine
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center (PICU / NICU)
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Akron Children's Hospital
Cleveland, Ohio, United States, 44313
United States, Oklahoma
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201-2701
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Utah
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84108
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Children's Hospital
Charlottesville, Virginia, United States, 22908-0386
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Manitoba
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hospital Sainte-Justine
Montreal, Quebec, Canada, T3T 1C5
Israel
Assaf Harofeh Medical Center
Zerifin, Tel Aviv, Israel, 70300
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Singapore
KK Women's and Children's Hospital Pte Ltd
Singapore, Singapore, 229899
United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
Sponsors and Collaborators
Daniel Benjamin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Investigators
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Principal Investigator: Michael Cohen-Wolkowiez, MD Duke University
Study Chair: Chiara Melloni, MD Duke University
Additional Information:
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Benjamin, Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT01431326    
Other Study ID Numbers: Pro00029638
IND 113645 ( Other Identifier: FDA )
IND 114369 ( Other Identifier: FDA )
IND 114531 ( 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 )
HHSN27500049 ( Other Grant/Funding Number: NICHD )
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
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 Study data may be posted to the NICHD Data and Specimen Hub (DASH)

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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:
adenovirus
anaesthetic
anesthesia
anticoagulant
anti-epileptic
anti-inflammatory
antimicrobial
anti-psychotic
antiviral
anxiety
anxiolysis
anxiolytic
autism
autistic disorder
benzodiazepine
bipolar disorder
convulsions
epilepsy
headaches
herpes simplex virus
herpes simplex virus (HSV)
hypertension
infantile hemangioma
infection
inflammation
influenza
lower respiratory tract infection (LRTI)
meningitis
migraines
muscle spasms
Additional relevant MeSH terms:
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Child Development Disorders, Pervasive
Infection
Communicable Diseases
Urinary Tract Infections
Meningococcal Infections
Respiratory Tract Infections
Staphylococcal Infections
Intraabdominal Infections
Healthcare-Associated Pneumonia
Sepsis
Toxemia
Meningitis, Bacterial
Adenoviridae Infections
Herpes Simplex
Cytomegalovirus Retinitis
Hemangioma
Hemangioma, Capillary
Muscle Cramp
Pneumonia
Epilepsy
Seizures
Meningitis
Spasm
Hyperkinesis
Central Nervous System Infections
Retinitis
Kidney Diseases
Renal Insufficiency, Chronic
Menorrhagia
Hypertension