Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Central Nervous System Infections, Chronic Kidney Diseases, CMV Retinitis, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Endocarditis, Epilepsy, Fibrinolytic Bleeding, General Anesthesia, Gram-negative Infection, Gynecologic Infections, Headache, Heart Failure, Heavy Menstrual Bleeding, Hemophilia, Herpes Simplex Virus, Hyperaldosteronism, Hypertension, Hypokalemia, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Insomnia, Intra-abdominal Infections, Lower Respiratory Tract Infections, Methicillin Resistant Staphylococcus Aureus, Migraines, Neuromuscular Blockade, Neutropenia, Nosocomial Pneumonia, Pain, Pneumonia, Pulmonary Arterial Hypertension, Schizophrenia, Sedation, Seizures, Sepsis, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Staphylococcal Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal

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, pain, pneumonia, prophylaxis, retinitis, schizophrenia, sedation, sedative, seizures, septicemia, swelling, urinary tract infection, urinary tract infection (UTI), withdrawal, empiric therapy, staphylococci, Fibrinolytic Bleeding, pulmonary arterial hypertension, CMV retinitis, control of serum phosphorus, Hyperaldosteronism, hypokalemia, heart failure, hemophilia, Heavy Menstrual Bleeding, insomnia

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).

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.

Canada, Israel, Singapore, United Kingdom, United States