Clinical Trial Details

NCT ID: NCT01431326
Date Last Changed: February 27, 2015

Overview

Research Study Summary

A clinical study for patients using Ampicillin

Research Study Title

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

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).

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
Up to 21 Years
Overall Status
Recruiting
Lead Sponsor
Daniel Benjamin
Duration
57 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages up to 21 Years

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.

Site Locations (27)

Country State City Zip Facility and Contact
United States Arkansas Little Rock 72202 Arkansas Children's Hospital
Lee Howard
501-364-3712
howardlee@uams.edu

Laura James, MD
Principal Investigator
United States California La Jolla 92093 University of California at San Diego Medical Center
Nancy Tang
858-246-0012
n6tang@ucsd.edu

Adriana Tremoulet, MD
Principal Investigator
United States California Los Angeles 90095 University of California, Los Angeles Medical Center
Kavita Shankar
310-794-6780
kshankar@mednet.ucla.edu

Jaime Deville, MD
Principal Investigator
United States Colorado Aurora 80045 The Children's Hospital Colorado
Kimberly Ralston
303-543-0731
kimberly.ralston@childrenscolorado.org

Peter Mourani, MD
Principal Investigator
United States Connecticut New Haven 06504 Yale New Haven Children's Hospital
Mathew Bizzarro
203-688-2320
matthew.bizzarro@yale.edu

Matthew Bizzarro, MD
Principal Investigator
United States Delaware Wilmington 19803 Alfred I. DuPont Hospital for Children
Kimberly Klipner
302-651-4088
kimberly.klipner@nemours.org

Glenn Stryjewski, MD
Principal Investigator
United States District of Columbia Washington 20010 Children's National Medical Center
Elaine Williams
202-884-2245
efwillia@cnmc.org

John van den Anker, MD, PhD, FAAP, FCP
Principal Investigator
United States Florida Jacksonville 32209 University of Florida Jacksonville Shands Medical Center
Kathleen Thoma
904-244-3059
kathleen.thoma@jax.ufl.edu

Mobeen Rathore, MD
Principal Investigator
United States Illinois Chicago 60614 Childrens Memorial Hospital
Laura Fearn
312-227-6285
lfearn@luriechildrens.org

Ram Yogev, MD
Principal Investigator
United States Indiana Indianapolis 46202 Riley Hosptial for Children at Indiana University
Lucy Smiley
317-274-7364
lcsmiley@iu.edu

Scott Denne, MD,
Principal Investigator
United States Kansas Wichita 67214 Wesely Medical Center
Paula Delmore
316-962-8580
paula.delmore@wesleymc.com

Paula Delmore, MSN
Principal Investigator
United States Kentucky Louisville 40202 Kosair Children's Hospital
Konow C Courtney
502-629-5262
courtney.konow@louisville.edu

Janice Sullivan, MD, FAAP, FCCM, CPI, CIP
Principal Investigator
United States Maryland Baltimore 21201 University of Maryland
Donna Cannonier
410-328-2438
dcannonier@peds.umaryland.edu

Susan Mendley, MD
Principal Investigator
United States North Carolina Chapel Hill 27599 UNC Hospital Neonatal-Perinatal Medicine
Janice Bernhardt
919-843-2373
bernhardt@unc.edu

Matthew Laughon, MD, MPH
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center
Samantha Wrenn
919-681-2554
samantha.wrenn@duke.edu

Kevin Watt, MD
Principal Investigator
United States Ohio Cincinnati 45229-3039 Cincinnati Childrens Hospital Medical Center
Tara Terrell
513-803-3294
Tara.Terrell@cchmc.org

Stuart Goldstein, MD
Principal Investigator
United States Ohio Cleveland 44313 Akron Children's Hospital
Heather Anthony, RN
330-543-0731
hanthony@chmca.org

Martha Blackford, PharmD
Principal Investigator
United States Ohio Cleveland 44106 Case Western University Hospitals of Cleveland
Ashlee Crumbly
216-844-3312
ashlee.crumbly@UHhospitals.org

David Speicher, MD
Principal Investigator
United States Oregon Portland 97201-2701 Oregon Health and Science University
Kira Clark
503-494-3044
clarki@ohsu.edu

Amira Al-Uzri, MD
Principal Investigator
United States South Carolina Charleston 29425 Medical University of South Carolina
Al Sarraf Layla
843-792-5309
alsarral@musc.edu

Andrew Atz, MD
Principal Investigator
United States Utah Salt Lake City 84108 University of Utah Hospitals and Clinics
Sharada Dixit, RN
801-213-7525
sharada.dixit@hsc.utah.edu

Michael Spigarelli, MD
Principal Investigator
United States Virginia Charlottesville 22908-0386 University of Virginia Children's Hospital
Robin Kelly
434-982-3973
rlk5a@virginia.edu

Michelle Adu-Darko, MD
Principal Investigator
United States Washington Seattle 98105 Seattle Children's Hospital
Megan Kelton-Rehkopf
206-884-1422
megan.keltonr@seattlechildrens.org

Joseph Flynn, MD
Principal Investigator
United States Wisconsin Milwaukee 53226 Medical College of Wisconsin
Shawna Joachim
414-955-2817
sjoahim@mcw.edu

Beth Drolet, MD
Principal Investigator
Israel Tel Aviv Zerifin 70300 Assaf Harofeh Medical Center
Matitiahu Berkovitch, MD
011-972-8-977-9152
mberkovitch@asaf.health.gov.il

Matitiahu Berkovitch, MD
Principal Investigator
Israel Petah Tikva 49202 Schneider Children's Medical Center of Israel
Yehezkel (Hezi) Waisman, MD
011-972-3-925-3661
waisy@clalit.org.il

Yehezkel (Hezi) Waisman, MD
Principal Investigator
Singapore Singapore 229899 KK Women's and Children's Hospital Pte Ltd
Jan Hau Lee, MD
1-65-9699-5200
lee.jan.hau@kkh.com.sg

Jan Hau Lee, MD
Principal Investigator

Contact

Chiara Melloni, MD
919-668-8646
E-mail:

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