Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
- Conditions
- Bacterial SepticemiaGeneral AnesthesiaGynecologic InfectionsMigrainesSeizuresAnxiolysisBenzodiazepineBone and Joint InfectionsCytomegalovirus RetinitisInfantile Hemangioma
- Registration Number
- NCT01431326
- Lead Sponsor
- Daniel Benjamin
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3520
-
- Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
-
- Failure to obtain consent/assent (as indicated)
-
- Known pregnancy as determined via interview or testing if available.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of pharmacokinetic outcomes for understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days As appropriate for each study drug, the following additional PK parameters will be estimated:
* maximum concentration (Cmax)
* time to achieve maximum concentration (Tmax)
* absorption rate constant (ka)
* elimination rate constant (kel)
* half-life (t1/2)
* area under the curve (AUC)
Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.
- Secondary Outcome Measures
Name Time Method Composite pharmacodynamic outcomes of understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations.
Biomarkers associated with understudied drugs in children Data will be collected throughout the hospital or outpatient stay up to 90 days The dosing, sampling, and demographic information recorded on the electronic data collection forms will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed.
Trial Locations
- Locations (52)
University of Maryland
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Schneider Children's Medical Center of Israel
🇮🇱Petah Tikva, Israel
KK Women's and Children's Hospital Pte Ltd
🇸🇬Singapore, Singapore
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Riley Hospital for Children at Indiana University
🇺🇸Indianapolis, Indiana, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
The Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Yale New Haven Children's Hospital
🇺🇸New Haven, Connecticut, 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
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
UNC Hospital Neonatal-Perinatal Medicine
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Alaska Native Medical Center
🇺🇸Anchorage, Alaska, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of California at San Diego Medical Center
🇺🇸La Jolla, California, United States
University of California, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, 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
Children's Mercy Hospital and Clinics
🇺🇸Kansas City, Kansas, United States
University of Montana
🇺🇸Missoula, Montana, United States
University of New Mexico, Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Akron Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Board of Regents of the University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Virginia Children's Hospital
🇺🇸Charlottesville, Virginia, United States
Duke University Medical Center (PICU / NICU)
🇺🇸Durham, North Carolina, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
Alder Hey Children's Hospital
🇬🇧Liverpool, Merseyside, United Kingdom
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Manitoba Institute of Child Health
🇨🇦Winnipeg, Manitoba, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hospital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Assaf Harofeh Medical Center
🇮🇱Zerifin, Tel Aviv, Israel
University of Kansas Medical Center
🇺🇸Fairway, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States