Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Duke University
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
Daniel Benjamin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01431326
First received: August 17, 2011
Last updated: December 31, 2013
Last verified: December 2013
  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 2000 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
Nausea
Edema
Hyperlipidemia
Hypotension
Hypercholesterolemia
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431326

Contacts
Contact: Chiara Melloni, MD 919-668-8646 chiara.melloni@dm.duke.edu
Contact: Barrie L Harper, MT (ASCP) 919-668-8291 barrie.harper@duke.edu

  Show 37 Study Locations
Sponsors and Collaborators
Daniel Benjamin
The EMMES Corporation
Investigators
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, IND 118329, IND 118358
Study First Received: August 17, 2011
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Cholera
infection
tinea
anesthesia
hypertension
pain
opioid addiction
reflux
UTI
bronchitis
diarrhea
cyanide poisoning
cardiac arrest
hypotension
cardiac arrhythmia
pneumonia
Rocky Mountain Spotted Fever
Q Fever
Anthrax
Tularemia
Trachoma
Psittacosis
Plague
Brucellosis
Bartonellosis
hypercholesterolemia
Heterozygous Familial Hypercholesterolemia (HeFH)
Primary Prevention of Coronary Events
Acute pulmonary edema
edema

Additional relevant MeSH terms:
Edema
Hypercholesterolemia
Hyperlipidemias
Hypertension
Hypotension
Nausea
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Digestive
Ampicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014