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Clinical Trial Details


Research Study Summary

A clinical study for patients using Ampicillin

Research Study Title

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care


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

Both Male and Female


Up to 21 Years

Overall Status


Lead Sponsor

Daniel Benjamin


45 Months

Facility Type



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

Laura James, MD
Principal Investigator
United States California La Jolla 92093 University of California at San Diego Medical Center
Nancy Tang

Adriana Tremoulet, MD
Principal Investigator
United States Colorado Aurora 80045 The Children's Hospital Colorado
Theresa Wilson

Peter Mourani, MD
Principal Investigator
United States Connecticut New Haven 06504 Yale New Haven Children's Hospital
Monica Konstantino

Matthew Bizzarro, MD
Principal Investigator
United States Delaware Wilmington 19803 Alfred I. DuPont Hospital for Children
Kimberly Klipner

Glenn Stryjewski, MD
Principal Investigator
United States District of Columbia Washington 20010 Children's National Medical Center
Elaine Williams

John van den Anker, MD, PhD, FAAP, FCP
Principal Investigator
United States Florida Jacksonville 32209 University of Florida Jacksonville Shands Medical Center
Kathleen Thoma

Mobeen Rathore, MD
Principal Investigator
United States Illinois Chicago 60614 Childrens Memorial Hospital
Carol Nielson

Ram Yogev, MD
Principal Investigator
United States Indiana Indianapolis 46202 Riley Hosptial for Children at Indiana University
Leslie Wilson

Brenda Poindexter, MD, MS
Principal Investigator
United States Kansas Wichita 67214 Wesely Medical Center
Paula Delmore

Paula Delmore, MSN
Principal Investigator
United States Kentucky Louisville 40202 Kosair Children's Hospital
Tressa C Bratton

Janice Sullivan, MD, FAAP, FCCM, CPI, CIP
Principal Investigator
United States Maryland Baltimore 21201 University of Maryland
Donna Cannonier

Susan Mendley, MD
Principal Investigator
United States Michigan Detroit 48201 Children's Hospital of Michigan
Chantel Karmo

Edward Dabrowski, MD
Principal Investigator
United States North Carolina Chapel Hill 27599 UNC Hospital Neonatal-Perinatal Medicine
Janice Bernhardt

Matthew Laughon, MD, MPH
Principal Investigator
United States North Carolina Durham 27710 Duke University Medical Center
Samantha Wrenn

Kevin Watt, MD
Principal Investigator
United States Ohio Cincinnati 45229-3039 Cincinnati Childrens Hospital Medical Center
Tara Terrell

Stuart Goldstein, MD
Principal Investigator
United States Ohio Cleveland 44313 Akron Children's Hospital
Eloise Lemon, RN

Michael Reed, PharmD
Principal Investigator
United States Ohio Cleveland 44106 Case Western University Hospitals of Cleveland
Catherine TAsi

David Speicher, MD
Principal Investigator
United States Oregon Portland 97201-2701 Oregon Health and Science University
Kira Clark

Amira Al-Uzri, MD
Principal Investigator
United States South Carolina Charleston 29425 Medical University of South Carolina
Patricia Infinger

Andrew Atz, MD
Principal Investigator
United States Utah Salt Lake City 84108 University of Utah Hospitals and Clinics
Tiffanie Hales

Michael Spigarelli, MD
Principal Investigator
United States Washington Seattle 98105 Seattle Children's Hospital
Megan Kelton-Rehkopf

Joseph Flynn, MD
Principal Investigator
Singapore Singapore 229899 KK Women's and Children's Hospital Pte Ltd
Jan Hau Lee, MD

Jan Hau Lee, MD
Principal Investigator


Chiara Melloni, MD

NCT ID: NCT01431326

Date Last Changed: July 30, 2014

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