Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)
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Purpose
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 500 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).
| Condition | Intervention |
|---|---|
|
Infection Hypertension Anesthesia Pain Reflux |
Drug: Ampicillin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care |
- Composite of pharmacokinetic outcomes for understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ] [ Designated as safety issue: No ]
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.
- Composite pharmacodynamic outcomes of understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ] [ Designated as safety issue: No ]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 [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ] [ Designated as safety issue: No ]The dosing, sampling, and demographic information recorded on the eCRF 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.
Biospecimen Retention: Samples With DNA
whole blood
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver
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.
Contacts and Locations| Contact: Michael Cohen-Wolkowiez, MD | 919-668-8812 | |
| Contact: Barrie L Harper, MT (ASCP) | 919-668-8291 | michael.cohenwolkowiez@duke.edu |
Show 28 Study Locations| Principal Investigator: | Michael Cohen-Wolkowiez, MD | Duke University |
| Study Chair: | Chiara Melloni, MD | Duke University |
More Information
Additional Information:
Publications:
| Responsible Party: | Daniel Benjamin, Professor of Pediatrics, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01431326 History of Changes |
| Other Study ID Numbers: | Pro00029638, IND 113645, IND 114369, IND 114531, IND 114892, IND 115226 |
| Study First Received: | August 17, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Rocky Mountain Spotted Fever infection tinea anesthesia hypertension pain opioid addiction reflux UTI bronchitis diarrhea cyanide poisoning cardiac arrest |
hypotension cardiac arrhythmia pneumonia Q Fever Anthrax Cholera Tularemia Trachoma Psittacosis Plague Brucellosis Bartonellosis |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Ampicillin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013