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Updated: May 10, 2026
A High-throughput Shigella-specific Bactericidal Assay
Published on: February 27, 2019
Effect of an oral Shiga toxin-binding agent on diarrhea-associated hemolytic uremic syndrome in children: a
Howard Trachtman1, Avital Cnaan, Erica Christen
1Department of Pediatrics, Schneider Children's Hospital of the North Shore-Long Island Jewish Medical Center, New Hyde Park, NY 11040, USA. trachtma@lij.edu
Insights
An oral Shiga toxin-binding agent did not reduce the severity of diarrhea-associated hemolytic uremic syndrome (HUS) in children. This study found no significant difference in death, serious events, or dialysis needs between treated and placebo groups.
Area of Science:
- Pediatric Nephrology
- Infectious Diseases
- Gastroenterology
Background:
- Diarrhea-associated hemolytic uremic syndrome (HUS) is a leading cause of acute kidney failure in children.
- Shiga toxin-producing Escherichia coli strains are the primary cause of HUS.
- Effective treatments to mitigate HUS severity are critical.
Purpose of the Study:
- To evaluate the efficacy of an oral Shiga toxin-binding agent in reducing HUS severity.
- To assess the impact of the agent on mortality and renal outcomes in pediatric HUS patients.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 145 pediatric patients.
- Patients received either the Shiga toxin-binding agent or a placebo for 7 days.
- Outcomes measured included death, serious extrarenal events, and need for dialysis.
Main Results:
- No significant difference in the combined frequency of death or serious extrarenal events between the experimental (18%) and placebo (20%) groups (P=.82).
- The need for dialysis was similar in both groups: 42% in the experimental group and 39% in the placebo group (P=.86).
- Disease severity at randomization was comparable between groups.
Conclusions:
- Oral therapy with a Shiga toxin-binding agent was ineffective in diminishing the severity of diarrhea-associated HUS in pediatric patients.
- Further research may be needed to explore alternative therapeutic strategies for HUS.
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.
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