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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01431326




Registration number
NCT01431326
Ethics application status
Date submitted
17/08/2011
Date registered
9/09/2011
Date last updated
6/09/2023

Titles & IDs
Public title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Scientific title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Secondary ID [1] 0 0
IND 113645
Secondary ID [2] 0 0
Pro00029638
Universal Trial Number (UTN)
Trial acronym
PTN_POPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenovirus 0 0
Anesthesia 0 0
Anxiety 0 0
Anxiolysis 0 0
Autism 0 0
Autistic Disorder 0 0
Bacterial Meningitis 0 0
Bacterial Septicemia 0 0
Benzodiazepine 0 0
Bipolar Disorder 0 0
Bone and Joint Infections 0 0
Central Nervous System Infections 0 0
Convulsions 0 0
Cytomegalovirus Retinitis 0 0
Early-onset Schizophrenia Spectrum Disorders 0 0
Epilepsy 0 0
General Anesthesia 0 0
Gynecologic Infections 0 0
Herpes Simplex Virus 0 0
Infantile Hemangioma 0 0
Infection 0 0
Inflammation 0 0
Inflammatory Conditions 0 0
Intra-abdominal Infections 0 0
Lower Respiratory Tract Infections 0 0
Migraines 0 0
Pain 0 0
Pneumonia 0 0
Schizophrenia 0 0
Sedation 0 0
Seizures 0 0
Skeletal Muscle Spasms 0 0
Skin and Skin-structure Infections 0 0
Treatment-resistant Schizophrenia 0 0
Urinary Tract Infections 0 0
Withdrawal 0 0
Sepsis 0 0
Gram-negative Infection 0 0
Bradycardia 0 0
Cardiac Arrest 0 0
Cardiac Arrhythmia 0 0
Staphylococcal Infections 0 0
Nosocomial Pneumonia 0 0
Neuromuscular Blockade 0 0
Methicillin Resistant Staphylococcus Aureus 0 0
Endocarditis 0 0
Neutropenia 0 0
Headache 0 0
Fibrinolytic Bleeding 0 0
Pulmonary Arterial Hypertension 0 0
CMV Retinitis 0 0
Hypertension 0 0
Chronic Kidney Diseases 0 0
Hyperaldosteronism 0 0
Hypokalemia 0 0
Heart Failure 0 0
Hemophilia 0 0
Heavy Menstrual Bleeding 0 0
Insomnia 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Skin 0 0 0 0
Other skin conditions
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Epilepsy
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Treatment: Drugs: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of pharmacokinetic outcomes for understudied drugs in children
Timepoint [1] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcome [1] 0 0
Composite pharmacodynamic outcomes of understudied drugs in children
Timepoint [1] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcome [2] 0 0
Biomarkers associated with understudied drugs in children
Timepoint [2] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days

Eligibility
Key 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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 1) Failure to obtain consent/assent (as indicated)

- 2) Known pregnancy as determined via interview or testing if available.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
Accrual to date
Final
3520
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
West Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Aviv
Country [39] 0 0
Israel
State/province [39] 0 0
Petah Tikva
Country [40] 0 0
Singapore
State/province [40] 0 0
Singapore
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Hampshire
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Merseyside

Funding & Sponsors
Primary sponsor type
Other
Name
Daniel Benjamin
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
The Emmes Company, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01431326
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Chi Hornik, PharmD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries