Clinical Trial Details

NCT ID: NCT01431326
Date Last Changed: March 21, 2017


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 3000 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).

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Recruitment Details

Up to 21 Years
Overall Status
Lead Sponsor
Daniel Benjamin
75 Months
Facility Type


All 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 (29)

Country State City Zip Facility and Contact
United States Arkansas Little Rock 72202 Arkansas Children's Hospital
Lee Howard

Laura James, MD
Principal Investigator
United States California Los Angeles 90095 University of California, Los Angeles Medical Center
Elizabeth Lang

Jaime Deville, MD
Principal Investigator
United States Colorado Aurora 80045 The Children's Hospital Colorado
Matthew Steinbess

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

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

Marisa Meyer, 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
Saniyyah Mahmoudi

Mobeen Rathore, MD
Principal Investigator
United States Illinois Chicago 60614 Lurie Children's Hospital of Chicago
Laura Fearn

Ram Yogev, MD
Principal Investigator
United States Indiana Indianapolis 46202 Riley Hospital for Children at Indiana University
Susan Gunn

Sokol Gregory, MD,
Principal Investigator
United States Kansas Wichita 67214 Wesely Medical Center
Paula Delmore

Paula Delmore, MSN
Principal Investigator
United States Kentucky Louisville 40202 Norton Children's Hospital
Jackie Perry

Janice Sullivan, MD, FAAP, FCCM, CPI, CIP
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 (PICU / NICU)
Samantha Wrenn

Kevin Watt, MD
Principal Investigator

Hornik Chi, PharmD
Principal Investigator
United States Ohio Cincinnati 45229-3039 Cincinnati Childrens Hospital Medical Center
Tara Terrell

Stuart Goldstein, MD
Principal Investigator
United States Ohio Cleveland 44106 Rainbow Babies and Children's Hospital
Eileen Goldblatt

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
Layla Al-Sarraf

Andrew Atz, MD
Principal Investigator
United States Utah Salt Lake City 84108 University of Utah Hospitals and Clinics
Sharada Dixit, RN

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

Joseph Flynn, MD
Principal Investigator
United States Wisconsin Milwaukee 53226 Medical College of Wisconsin
Katherine Mueller

Beth Drolet, MD
Principal Investigator
Canada Manitoba Winnipeg R3E 3P4 Manitoba Institute of Child Health
Jeannine Schellenberg

Geert T'Jong, MD
Principal Investigator
Canada Ontario Ottawa K1H 8L1 Children's Hospital of Eastern Ontario
Angie Tuttle
613-737-7600 ext. 6058

Hugh McMillan, MD
Principal Investigator
Canada Ontario Toronto M5G 1X8 The Hospital for Sick Children
Maggie Rumantir, MD
1-416-813-7654 ext. 309153

Yaron Finkelstein, MD
Principal Investigator
Canada Quebec Montreal T3T 1C5 Hospital Sainte-Justine
Mariana Dumitrascu
1-514-345-4931 ext. 6648

Julie Autmizguine, MD
Principal Investigator
Israel Tel Aviv Zerifin 70300 Assaf Harofeh Medical Center
Matitiahu Berkovitch, MD

Matitiahu Berkovitch, MD
Principal Investigator
Israel Petah Tikva 49202 Schneider Children's Medical Center of Israel
Nava Mattiyahu

Yehezkel (Hezi) Waisman, 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
United Kingdom Hampshire Southampton SO16 6YD Southampton General Hospital
Danny Pratt

Iain Macintosh, MD
Principal Investigator
United Kingdom Merseyside Liverpool L12 2AP Alder Hey Children's Hospital
Laura Walsh
011-4401512525570 ext. 3552

Dan Hawcutt, MD
Principal Investigator


Chiara Melloni, MD

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