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Trial record 40 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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

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ClinicalTrials.gov Identifier: NCT01431326
Recruitment Status : Recruiting
First Posted : September 9, 2011
Last Update Posted : April 4, 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

Tracking Information
First Submitted Date August 17, 2011
First Posted Date September 9, 2011
Last Update Posted Date April 4, 2019
Study Start Date November 2011
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2011)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01431326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 2, 2018)
  • 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 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.
Original Secondary Outcome Measures
 (submitted: September 7, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Official Title Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
Condition
  • 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
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2017)
10000
Original Estimated Enrollment
 (submitted: September 7, 2011)
500
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Barrie Harper, MT (ASCP), PMP 919-668-8291 barrie.harper@duke.edu
Contact: POP01 StudyMailbox POP01@dm.duke.edu
Listed Location Countries United States,   Australia,   Canada,   Israel,   Singapore,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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)
Responsible Party Daniel Benjamin, Duke University
Study Sponsor Daniel Benjamin
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC
Investigators
Principal Investigator: Michael Cohen-Wolkowiez, MD Duke University
Study Chair: Chiara Melloni, MD Duke University
PRS Account Duke University
Verification Date April 2019