 |
|
Effect of an Oral Shiga Toxin–Binding Agent on Diarrhea-Associated Hemolytic Uremic Syndrome in Children
A Randomized Controlled Trial
Howard Trachtman, MD;
Avital Cnaan, PhD;
Erica Christen, RN;
Kathleen Gibbs, MSIS;
Sanyi Zhao, MS;
David W. K. Acheson, MD;
Robert Weiss, MD;
Frederick J. Kaskel, MD, PhD;
Adrian Spitzer, MD;
Gladys H. Hirschman, MD; for the Investigators of the HUS-SYNSORB Pk Multicenter Clinical Trial
JAMA. 2003;290:1337-1344.
Context Diarrhea-associated hemolytic uremic syndrome (HUS) is the most common cause of acute renal failure in children. Most cases are caused by an intestinal infection with Shiga toxin–producing strains of Escherichia coli.
Objective To determine if administration of an oral agent that binds Shiga toxin could diminish the severity of diarrhea-associated HUS in pediatric patients.
Design, Setting, and Patients Multicenter, randomized, double-blind, placebo-controlled clinical trial of 145 children (96 experimental and 49 placebo) aged 6 months to 18 years with diarrhea-associated HUS conducted between July 27, 1997, and April 14, 2001, at 26 tertiary care pediatric nephrology centers in the United States and Canada. Trial included 2 phases, the hospital course for treatment of the acute illness and a 60-day outpatient follow-up period after discharge from the hospital.
Intervention Patients were assigned to receive the binding agent, 500 mg/kg daily, or cornmeal placebo orally for 7 days in a 2:1 randomization scheme.
Main Outcome Measures Combined frequency of death or serious extrarenal events and need for dialysis in the experimental vs placebo group.
Results A total of 62 patients (43%) were male and 123 (85%) were white. The median age of the patients was 4.2 years. Most patients (59%) were transferred from other hospitals to participating sites. The severity of disease at the time of randomization was comparable in the 2 groups. The prevalence of death or serious extrarenal events was 18% and 20% in the experimental and placebo groups, respectively (P = .82). Dialysis was required in 42% of experimental and 39% of placebo groups (P = .86).
Conclusions Oral therapy with a Shiga toxin–binding agent failed to diminish the severity of disease in pediatric patients with diarrhea-associated HUS.
Author Affiliations: Department of Pediatrics, Schneider Children's Hospital of the North Shore–Long Island Jewish Medical Center, New Hyde Park, NY (Dr Trachtman and Ms Christen); Department of Biostatistics and Epidemiology, Children's Hospital of Philadelphia, Philadelphia, Pa (Dr Cnaan and Mss Gibbs and Zhao); Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore (Dr Acheson); Department of Pediatrics, New York Medical College, Valhalla (Dr Weiss); Department of Pediatrics, Children's Hospital of Montefiore, Bronx, NY (Drs Kaskel and Spitzer); and National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Kidney and Urology Program, Bethesda, Md (Dr Hirschman).
RELATED ARTICLES
Long-term Renal Prognosis of Diarrhea-Associated Hemolytic Uremic Syndrome: A Systematic Review, Meta-analysis, and Meta-regression
Amit X. Garg, Rita S. Suri, Nick Barrowman, Faisal Rehman, Doug Matsell, M. Patricia Rosas-Arellano, Marina Salvadori, R. Brian Haynes, and William F. Clark
JAMA. 2003;290(10):1360-1370.
ABSTRACT
| FULL TEXT
Postdiarrheal Shiga Toxin–Mediated Hemolytic Uremic Syndrome
Richard L. Siegler
JAMA. 2003;290(10):1379-1381.
EXTRACT
| FULL TEXT
Food-Borne Illnesses
Sharon Parmet, Cassio Lynm, and Richard M. Glass
JAMA. 2003;290(10):1408.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Environmental prevention of human disease from verocytotoxin-producing Escherichia coli
Khanna et al.
Nephrol Dial Transplant 2008;23:1819-1822.
ABSTRACT
| FULL TEXT
Characterization of a Human Monoclonal Antibody against Shiga Toxin 2 Expressed in Chinese Hamster Ovary Cells
Akiyoshi et al.
Infect. Immun. 2005;73:4054-4061.
ABSTRACT
| FULL TEXT
Hemolytic Uremic Syndrome
Noris and Remuzzi
J. Am. Soc. Nephrol. 2005;16:1035-1050.
FULL TEXT
Verotoxin (Shiga Toxin) Sensitizes Renal Epithelial Cells to Increased Heme Toxicity: Possible Implications for the Hemolytic Uremic Syndrome
Bitzan et al.
J. Am. Soc. Nephrol. 2004;15:2334-2343.
ABSTRACT
| FULL TEXT
Escherichia coli Serogroup O107/O117 Lipopolysaccharide Binds and Neutralizes Shiga Toxin 2
Gamage et al.
J. Bacteriol. 2004;186:5506-5512.
ABSTRACT
| FULL TEXT
Lucina
Arch. Dis. Child. 2004;89:396-396.
FULL TEXT
Oral Therapy with a Shiga Toxin-Binding Agent for HUS
Friedman
AAP Grand Rounds 2003;10:75-75.
FULL TEXT
Postdiarrheal Shiga Toxin-Mediated Hemolytic Uremic Syndrome
Siegler
JAMA 2003;290:1379-1381.
FULL TEXT
|
