An observational study in Adenovirus, Anesthesia and Anxiety, sponsored by Daniel Benjamin. Completed at 52 sites in 5 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Daniel Benjamin · Observational
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).
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.
136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.
This study's enrollment of 3,520 is above the median of 800 across 16 observational studies indexed under Adenoviridae Infections.
Browse Adenoviridae Infections studies →Daniel Benjamin is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Children (\<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
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Exclusion Criteria:
Also known as: cidofovir, ciprofloxacin, methylprednisolone, tobramycin, alfentanil, clozapine, haloperidol, lurasidone, molindone, pentobarbital, warfarin (oral), ziprasidone, amikacin, cefepime, nafcillin, piperacillin-tazobactam, rocuronium, vecuronium, vancomycin, aminocaproic acid, bosentan, fosfomycin, labetalol, nifedipine, oxycodone, sevelamer carbonate, spironolactone, tranexamic acid, zolpidem
Composite of pharmacokinetic outcomes for understudied drugs in children
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.
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Composite pharmacodynamic outcomes of understudied drugs in children
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.
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Biomarkers associated with understudied drugs in children
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.
Time frame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Plan to share: No — Completed study datasets (limited PHI) may be requested from https://pediatrictrials.org/data-sharing-opportunities Study data may be posted to the NICHD Data and Specimen Hub (DASH)
Ran from Nov 2011 to primary completion in Nov 2019, 96 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Daniel Benjamin