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

Daniel Benjamin

Status

Completed

Conditions

Hypokalemia

Neutropenia

Bipolar Disorder

CMV Retinitis

Skeletal Muscle Spasms

Insomnia

Fibrinolytic Bleeding

Heavy Menstrual Bleeding

Withdrawal

Schizophrenia

Endocarditis

Bone and Joint Infections

Sedation

Pneumonia

Inflammatory Conditions

Seizures

Urinary Tract Infections

Infection

Adenovirus

Central Nervous System Infections

Headache

Pulmonary Arterial Hypertension

Bacterial Septicemia

Convulsions

Methicillin Resistant Staphylococcus Aureus

General Anesthesia

Cardiac Arrhythmia

Hyperaldosteronism

Cytomegalovirus Retinitis

Intra-abdominal Infections

Anxiolysis

Benzodiazepine

Infantile Hemangioma

Gynecologic Infections

Neuromuscular Blockade

Autistic Disorder

Early-onset Schizophrenia Spectrum Disorders

Nosocomial Pneumonia

Treatment-resistant Schizophrenia

Pain

Gram-negative Infection

Bradycardia

Chronic Kidney Diseases

Bacterial Meningitis

Inflammation

Staphylococcal Infections

Herpes Simplex Virus

Heart Failure

Anxiety

Cardiac Arrest

Skin and Skin-structure Infections

Autism

Sepsis

Hypertension

Epilepsy

Migraines

Hemophilia

Lower Respiratory Tract Infections

Anesthesia

Treatments

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

Study type

Observational

Funder types

Other

Industry

NIH

Identifiers

NCT01431326

HHSN27500043 (Other Grant/Funding Number)

IND 118358 (Other Identifier)

HHSN27500020 (Other Grant/Funding Number)

HHSN27500049 (Other Grant/Funding Number)

HHSN20100006 (Other Grant/Funding Number)

IND 114531 (Other Identifier)

HHSN27500027 (Other Grant/Funding Number)

IND 114369 (Other Identifier)

Pro00029638

IND 113645 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

3,520 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers