Vanderbilt
University
Medical
Center
will embark on a phase one clinical trial of a new product that could be used in children to protect them from hemolytic uremic syndrome (HUS). Vanderbilt will be the only site in the country testing this new product.
HUS is a leading cause of acute renal failure in children and is typically a complication that may follow infection from E. coli. There are few options currently available for the prevention and treatment of HUS. It is hoped that this antibody can be given at the onset of symptoms and prevent HUS from developing.
The Vanderbilt research study will determine the safest and most effective dose of the investigational product, a protein called a monoclonal antibody (chimeric anti-shiga toxin 1 (c·Stx1). This study is the first time c·Stx1 is being given to humans. Four different dosages of the product will be evaluated and 25 adults will be screened.
“The intended usage of this product is to protect children infected with E. coli-producing Stxs against developing hemolytic uremic syndrome,” explained Kathryn Edwards M.D., principal investigator for the study.”
C·Stx1 was created to prevent E.coli infections from progressing to Hemolytic Uremic Syndrome (HUS). HUS is a complication that may follow certain food borne infections. HUS may cause kidney failure, anemia and bleeding problems. HUS is most commonly found in children and the elderly. HUS is very serious in children and is a leading cause of kidney failure.
This study is a “dose escalation” study. To determine the highest and safest dose, participants will receive different dose levels of the drug. Volunteers will be split into groups. The first group will receive the lowest dose level. If no severe side effects are noted, the dose will be increased for the next group of participants.
For every group of participants, the dose will be increased unless participants have side effects. If there are side effects, more participants may receive the lower dose
.
Up to 25 volunteers will take part in this study at VUMC. For more information contact Deborah Hunter at: Deborah.Hunter@Vanderbilt.edu.