Summary

for people ages up to 21 years (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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).

Details

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.

Keywords

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 Thromboprophylaxis Thrombosis 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 anaesthetic anticoagulant anti-epileptic anti-inflammatory antimicrobial anti-psychotic antiviral anxiolytic headaches herpes simplex virus (HSV) hypertension influenza lower respiratory tract infection (LRTI) meningitis muscle spasms prophylaxis retinitis sedative septicemia swelling urinary tract infection urinary tract infection (UTI) empiric therapy staphylococci Disease Communicable Diseases Migraine Disorders Heart Arrest Respiratory Tract Infections Adenoviridae Infections Herpes Simplex Hemangioma Arrhythmias, Cardiac Intraabdominal Infections Hemangioma, Capillary Port-Wine Stain Toxemia Meningitis, Bacterial Spasm Dexmedetomidine Hydromorphone Valproic Acid Methylprednisolone Ciprofloxacin Piperacillin Piperacillin, tazobactam drug combination The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Eligibility

You can join if…

Open to people ages up to 21 years

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

You CAN'T join if...

  • 1) Failure to obtain consent/assent (as indicated)
  • 2) Known pregnancy as determined via interview or testing if available.

Locations

  • University of California at San Diego Medical Center in progress, not accepting new patients
    La Jolla California 92093 United States
  • Axis Clinical Trials terminated
    Los Angeles California 90036 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daniel Benjamin
ID
NCT01431326
Study Type
Observational
Last Updated
April 2, 2018