Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed
Conditions studied: 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
In brief
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).
Key facts
- Study ID
- NCT01431326
- Run by
- Daniel Benjamin
- People needed
- 3520
- Starts
- 2011-11-01
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2023-09-06
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
You may not qualify if…
- 1) Failure to obtain consent/assent (as indicated)
- 2) Known pregnancy as determined via interview or testing if available.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- University of California at San Diego Medical Center — La Jolla, California, United States
- Axis Clinical Trials — Los Angeles, California, United States
- University of California, Los Angeles Medical Center — Los Angeles, California, United States
- The Children's Hospital Colorado — Aurora, Colorado, United States
- Yale New Haven Children's Hospital — New Haven, Connecticut, United States
- Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- University of Florida Jacksonville Shands Medical Center — Jacksonville, Florida, United States
- Kapiolani Womens and Childrens Medical Center — Honolulu, Hawaii, United States
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Riley Hospital for Children at Indiana University — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Fairway, Kansas, United States
- Children's Mercy Hospital and Clinics — Kansas City, Kansas, United States
- Wesley Medical Center — Wichita, Kansas, United States
- Norton Children's Hospital — Louisville, Kentucky, United States
- Tulane University Health Science Center — New Orleans, Louisiana, United States
- Ochsner Baptist Clinical Trials Unit — New Orleans, Louisiana, United States
- University of Maryland — Baltimore, Maryland, United States
- Children's Hospital of Michigan — Detroit, Michigan, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
- University of Montana — Missoula, Montana, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Alaska Native Medical Center — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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