Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

CompletedNCT01431326

View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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).

Study details

Official title: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
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:
Sponsor: Daniel Benjamin
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The Emmes Company, LLC
Organization: Duke University
Start date: 2011-11
Primary completion: 2019-11
Sex: All
Age range: to 21 Years
Results posted: No results posted in this snapshot
Countries: Canada, Israel, Singapore, United Kingdom, United States
Total sites listed: 52

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

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.

Canadian sites (4)

Facility	City	Province
Manitoba Institute of Child Health	Winnipeg	Manitoba
Children's Hospital of Eastern Ontario	Ottawa	Ontario
The Hospital for Sick Children	Toronto	Ontario
Hospital Sainte-Justine	Montreal	Quebec

Canadian sites for NCT01431326. 4 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01431326