Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

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).

Conditions

• 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

Interventions

DRUG

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• Daniel Benjamin

  lead OTHER

Principal Investigators

• Chi Hornik, PharmD · Duke University

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2019-11-30

Completion

2019-11-30

FDA Drug

Yes

Countries

• United States
• Canada
• Israel
• Singapore
• United Kingdom

Study Locations