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University of Louisville Kosair Charities Pediatric Clinical Research Unit

Center Information

Janice E. Sullivan
M.D., FAAP, FCCM, CPI, CIP
Division Chief and Medical Director
University of Louisville Kosair Charities Pediatric Clinical Research Unit
231 E Chestnut St N-97
Louisville, KY 40202
USA
502-629-5820
502-629-5285 (fax)
kcpcru@louisville.edu
uofl.me/kcpcru16
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Devices
Endocrinology
Gastroenterology
Genetic Disease
Hematology
Infections and Infectious Diseases
Nephrology
Neurology
Nutrition and Weight Loss
Oncology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology

Center Overview

The Kosair Charities Pediatric Clinical Research Unit (KCPCRU) exists to:

  1. Design and conduct collaborative, multi-centered clinical trials for the purpose of generating high-quality scientific and clinical data to support the age-appropriate labeling of new and currently marketed agents in newborns, infants, children and adolescents.
  2. Characterize the collective effects of genetics, disease, environment and normal growth and development on drug disposition, response and toxicity using a translational science approach (i.e. develop precision medicine).
  3. Provide local and national leadership in the area of research ethics and compliance, including original research on ethical issues in pediatric clinical trials and translational genomics.
  4. Promote the education and development of students, residents, fellows and junior faculty in the disciplines of Pediatric Clinical Pharmacology and Research Ethics.
  5. Provide the highest quality of pharmaceutical care to children in the Kentuckiana region.
  6. Provide support and support services through the Faculty Development Program and to trainees and faculty within the Divisions to strengthen the research core within the Department of Pediatrics.

KCPCRU staff includes 28 team members, including experienced clinical research coordinators, subject recruiters, research nurses, research budget administrators, and regulatory coordinators. KCPCRU team members work together to coordinate clinical and translational patient-oriented research. Both in-patient and out-patient clinical studies are conducted through the KCPCRU.

The KCPCRU was established in 2002 as a joint effort between the University of Louisville, Norton Children's Hospital and Kosair Charities. The center was part of the NIH funded Pediatric Pharmacology Research Unit Network from 2004 to 2010. It currently collaborates with the Pediatric Trial Network from Duke University and is a site in the IDeA States Pediatric Trials Network. In additional to trials conducted through these networks, the KCPCRU participates in other NIH subcontracts, investigator-initiated projects, and industry-sponsored trials.

Clinical Research Experience

Studies have included the following diagnoses but is not limited to these:

Asthma
Autism
Bacterial Infection
Colic
Congenital Heart Disease
Constipation
Cystic Fibrosis
Device studies
Diabetes
Fragile X
Gastric esophageal reflux (GERD)
Genetic metabolic disorders
Hemophilia
Hyperbilirubinemia
Hyperglycemia
Hypertension
Immunosuppresion
Infections
Juvenile Rheumatoid Arthritis
Morquio A Syndrome
Neonatal studies
Respiratory Distress Syndrome
Sedation
Seizures
Septic Shock
Sickle Cell Disease
Pain Control
PKU
Platelet inhibition
Post operative nausea/vomiting
Septic shock
Viral illnesses

KCPCRU has been involved in clinical research since 2002.

Facility Description

The clinical facilities of the KCPCRU (approximately 5,400 square feet) are located on the second floor of Norton Children’s Hospital. There are three private inpatient rooms dedicated solely for infants, children and adolescents participating in clinical pharmacology and device research studies. The unit also contains a specimen-processing laboratory and satellite research pharmacy.

Investigator Experience

Janice E. Sullivan, M.D., FAAP, FCCM, CPI, CIP, Chief and Medical Director (Pediatric Critical Care and Clinical Pharmacology)

Kyle Brothers, M.D., PhD. (Ethics and Genetics)

Tania Condurache, M.D. (Hospital Medicine and International Health)

Esther E. Knapp, M.D., MBE (Ethics and Genetics)

Sarah E. Watson, M.D. (Pediatric Endocrinology and Clinical Research)

Staff Expertise

Kimberly Blair, BS, Unit Business Manager
Katie Weber, BA, Administrative Assistant
Kim Skaggs, MBA, Research Grants Coordinator
Taymie Collins,, Research Grants Coordinator

Sarah Penny, Regulatory Manager/Start-Up Specialist
Terri Boles, Regulatory Coordinator
Alyssa Middleton, M.S.W. , Regulatory Coordinator
Maria Bruner, Regulatory Coordinator
Missi Thomas, RN, BSN, CCRC, Feasibility Coordinator

Stephany Eubanks, RN, BSN, CCRC, Clinical Team Leader
Kristen Lee, BS, CCRC, Clinical Team Leader
Jen Comings, RN, BSN, Clinical Team Leader
Jackie Boyd, RN, BSN, CHPE, Clinical Team Leader

Barbara Keijner, RN, Clinical Research Nurse
Andrew Michael, RN, BSN, Clinical Research Nurse
Jennifer Nason, RN, BSN, Clinical Research Nurse
Tonya Shaffer, RN, BSN, Clinical Research Nurse
Terri Simeon, RN, Clinical Research Nurse
Morgan Talbot, RN, BSN, Clinical Research Nurse
Molly Harper, BA, CCRC, Clinical Research Coordinator
Carla Rich, MA, Clinical Research Coordinator
Luke Stephens, Clinical Research Coordinator

Trisha Aponte, BA, Research Assistant
Kayleah Sauer Barnes, BS, Research Assistant
Michelle Wiseheart, BS, Research Assistant
Josie Timmons, Research Assistant
Randi Mysinger, Research Assistant
Laura Thomas, RN, BSN, CCRN, Research Assistant
Tara Thomas, RD, LD, Research Assistant

Patient Demographics

KCPCRU is located in downtown Louisville and serves patients from Kentucky and Southern Indiana. In addition, we have collaborated with patients seeking participation in our studies nationwide.

Our faculty practices and community partners serve a unique patient population. According to American Community Survey data, over 82,000 African-American children and 34,000 Hispanic children live in Louisville/Jefferson County. Outside the city, Appalachian and rural populations, including a significant number of children from underserved minorities, receive care at outreach clinics and through partner organizations.

Norton Children’s Hospital (NCH) is a freestanding 263-bed academic pediatric medical center located in Louisville, Kentucky that provides comprehensive primary, tertiary, and quaternary specialty care to neonates, infants, children and adolescents. The catchment area for this institution has a population of approximately 4.5 million people, the majority of which reside in Louisville and western Kentucky. In addition, NCH has several outpatient and neonatal facilities throughout the Commonwealth of Kentucky.

Ambulatory care services for the Department of Pediatrics are provided at on-campus and off-campus General Pediatric sites. Collectively, these sites are responsible for the primary care of over 25,000 pediatric patients. Additional outpatient pediatric subspecialty clinics are also located in NCH and adjacent medical office buildings as well as several locations throughout the state.

Other Information

The KCPCRU currently utilizes the University of Louisville IRB which is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. However, on a case-by-case basis we are exploring the use of a central IRB for clinical trials.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.