Contact Maureen McArthur

~

For more information about the clinical trial, please call UK Health Connection at (606) 257-1000 or (800) 333-8874.

~

The Phase III clinical trial will evaluate SYNSORB Pk^® – a potential drug that may prevent hemolytic uremic syndrome (HUS), the leading cause of childhood acute kidney failure. Most cases of HUS in children result from infection with verotoxigenic strains of E. coli (VTEC), particularly E. coli O157:H7, after eating or drinking a contaminated item.

"Currently, there is no treatment to prevent the development of HUS in children with E. coli O157:H7 gastroenteritis," said Jens Goebel, assistant professor, Department of Pediatrics, pediatric nephrology division, UK College of Medicine and principal investigator at UK for the study. "We hope that this drug will prove to be an effective preventive measure by binding the toxin in the digestive tract and preventing it from reaching the blood stream."

The first known outbreak of illness caused by E. coli O157:H7, or O157 for short, occurred in 1982. The source of the bacteria was determined to be undercooked hamburgers.

The strain is now found in about one of every 100 healthy cattle.

Most infections are caused by eating undercooked ground beef that was contaminated during processing of the meat. Infections also can be caused by: drinking unpasteurized milk contaminated by bacteria from the cow’s udders; eating foods, such as alfalfa sprouts, that have been contaminated by fecal material from infected cows; and swimming in or drinking natural water contaminated with infected fecal matter. Furthermore, a HUS outbreak in Georgia last year has been linked to insufficient chlorination of a public pool. The bacteria also can be passed from person to person with insufficient hand washing.

Summer, being the barbecue season, typically is the peak time of the year for O157 infection and HUS.

Every year, about 20,000 people are infected with O157, leading to gastroenteritis, an acute inflammation of the lining of the stomach and intestines. About 250 people die from the infection or subsequent HUS, which develops in up to 25 percent of children with O157 gastroenteritis, although only about 10 percent develop clinically-relevant HUS.

HUS is caused by a toxin released by O157. The toxin is absorbed into the blood stream from the intestines and causes inflammation and blood clots in organs, particularly the kidneys, leading to kidney failure and possibly damage to the heart, pancreas, or brain.

HUS frequently requires intensive care, possibly including blood transfusions and dialysis. Up to 5 percent of patients with HUS die, up to one-third may experience kidney problems later in life, and about 8 percent have permanent complications such as high blood pressure, seizures, blindness or paralysis.

There is no evidence that antibiotic treatment is effective for O157 poisoning, and it may possibly lead to a greater chance of developing HUS.

SYNSORB Pk^® is an investigational new drug in powder form that binds to the toxin released by O157.

The study is sponsored by SYNSORB Biotech and is being conducted in cooperation with the Kentucky Center for Clinical Research and Investigator Services (KCCRIS) at UK.

Ways to prevent E. coli O157:H7 infection:

• Handle all ground beef properly.

• Use within 48 hours of purchase.
• Store on the lowest refrigerator rack to prevent juices from dripping on other foods or freeze it.
• If frozen, defrost in the refrigerator or microwave, not on the counter top.
• Wash hands, surfaces, plates and utensils after contact with raw ground meat and before contact with other food.
• Do not eat undercooked (i.e., pink) ground beef.

• Wash all raw fruits and vegetables thoroughly.
• Wash hands thoroughly.
• Do not use or drink unpasteurized juices or unpasteurized milk and milk products.
• Avoid non-municipal, non-chlorinated water.
• Use appropriate precautions in pools for infants or toddlers in diapers (i.e., waterproof swimwear).
• Feed cattle hay for five days before slaughter.