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Clinical Trial Details

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
Gender

Both Male and Female

Age

Up to 21 Years

Overall Status

Recruiting

Lead Sponsor

Daniel Benjamin

Duration

31 Months

Facility Type

N/A

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 (23)

Country State City Zip Facility and Contact
United States Arkansas Little Rock 72202 Arkansas Children's Hospital
Michelle Hart
501-364-1418
hartm@archildrens.org

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 Colorado Aurora 80045 The Children's Hospital Colorado
Theresa Wilson
720-777-7351
theresa.wilson@childrenscolorado.org

Peter Mourani, MD
Principal Investigator
United States Connecticut New Haven 06504 Yale New Haven Children's Hospital
Monica Konstantino
203-688-2320
monica.konstantino@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
Carol Nielson
312-227-8272
cnielsen@luriechildrens.org

Ram Yogev, MD
Principal Investigator
United States Indiana Indianapolis 46202 Riley Hosptial for Children at Indiana University
Leslie Wilson
317-274-8255
ldw@iu.edu

Brenda Poindexter, MD, MS
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
Tressa C Bratton
502-629-5604
tchent01@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 Michigan Detroit 48201 Children's Hospital of Michigan
Chantel Karmo
248-737-5939
chantel.karmo@dcrc.us

Edward Dabrowski, 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
Eloise Lemon, RN
330-543-3193
ELemon@chmca.org

Michael Reed, PharmD
Principal Investigator
United States Ohio Cleveland 44106 Case Western University Hospitals of Cleveland
Catherine TAsi
216-844-3312
Catherine.Tasi@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
Patricia Infinger
843-792-7857
infingep@musc.edu

Andrew Atz, MD
Principal Investigator
United States Utah Salt Lake City 84108 University of Utah Hospitals and Clinics
Tiffanie Hales
801-213-3367
tiffanie.hales@hsc.utah.edu

Michael Spigarelli, 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
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

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01431326

Date Last Changed: December 31, 2013

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