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NCT Number: NCT01431326

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

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).

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Key information

Conditions

Adenovirus Adenoviridae Infections Adrenal Gland Diseases Adrenocortical Hyperfunction Agranulocytosis Anesthesia Anxiety Anxiety Disorders Anxiolysis Arrhythmias, Cardiac Autism Autism Spectrum Disorder Autistic Disorder Bacterial Infections Bacterial Infections and Mycoses Bacterial Meningitis Bacterial Septicemia Benzodiazepine Bipolar Disorder Bipolar and Related Disorders Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Bone and Joint Infections Bradycardia Brain Diseases CMV Retinitis Cardiac Arrest Cardiac Arrhythmia Cardiovascular Diseases Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Child Development Disorders, Pervasive Chronic Disease Chronic Kidney Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Convulsions Cross Infection Cytomegalovirus Infections Cytomegalovirus Retinitis Cytopenia DNA Virus Infections Disease Attributes Dyssomnias Early-onset Schizophrenia Spectrum Disorders Endocarditis Endocrine System Diseases Epilepsy Eye Diseases Eye Infections Eye Infections, Viral Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrinolytic Bleeding General Anesthesia Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Gram-Positive Bacterial Infections Gram-negative Infection Gynecologic Infections Headache Headache Disorders Headache Disorders, Primary Healthcare-Associated Pneumonia Heart Arrest Heart Diseases Heart Failure Heavy Menstrual Bleeding Hemangioma Hemangioma, Capillary Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemorrhage Hemorrhagic Disorders Herpes Simplex Herpes Simplex Virus Herpesviridae Infections Hyperaldosteronism Hypertension Hypertension, Pulmonary Hypokalemia Iatrogenic Disease Infantile Hemangioma Infection Infections Inflammation Inflammatory Conditions Influenza, Human Insomnia Intra-Abdominal Infections Intraabdominal Infections Kidney Diseases Leukocyte Disorders Leukopenia Lower Respiratory Tract Infections Lung Diseases Male Urogenital Diseases Meningitis Meningitis, Bacterial Menorrhagia Menstruation Disturbances Mental Disorders Metabolic Diseases Methicillin Resistant Staphylococcus Aureus Migraine Disorders Migraines Mood Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Nervous System Diseases Neurodevelopmental Disorders Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Blockade Neuromuscular Manifestations Neutropenia Nosocomial Pneumonia Nutritional and Metabolic Diseases Orthomyxoviridae Infections Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Arterial Hypertension RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Retinal Diseases Retinitis Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Sedation Seizures Sepsis Signs and Symptoms Skeletal Muscle Spasms Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Skin and Skin-structure Infections Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spasm Staphylococcal Infections Systemic Inflammatory Response Syndrome Treatment-resistant Schizophrenia Urinary Tract Infections Urogenital Diseases Urologic Diseases Uterine Diseases Uterine Hemorrhage Vascular Diseases Virus Diseases Water-Electrolyte Imbalance Withdrawal

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manitoba Institute of Child Health, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Daniel Benjamin

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC

Registry information

Acronym: PTN_POPS

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2011
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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