Trials / Completed
CompletedNCT01431326
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,520 (actual)
- Sponsor
- Daniel Benjamin · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2019-11-01
- Completion
- 2019-11-01
- First posted
- 2011-09-09
- Last updated
- 2023-09-06
Locations
52 sites across 5 countries: United States, Canada, Israel, Singapore, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01431326. Inclusion in this directory is not an endorsement.