Phase 3
6 Months
18 Years
6 Months
18 Years
Not Enrolling
Both
Hemolytic Uremic Syndrome
Both
Hemolytic Uremic Syndrome
Trial Information
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are randomized to receive either SYNSORB Pk or placebo.
Patients receive oral SYNSORB Pk or placebo three times daily for 7 days. Patients are
followed on days 7, 14, 28, and 60 after discharge from the hospital.
Inclusion Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome
(HUS)
- Diarrheal prodrome within 7 days before onset of disease
- No HUS associated with the following: Hereditary Post-bone marrow transplantation
Streptococcus pneumoniae infection
- No prior catastrophic complications
--Patient Characteristics--
- Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells
- Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying
glomerular disease
- Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of
the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Howard Trachtman
Investigator Role:
Study Chair
Investigator Affiliation:
Long Island Jewish Medical Center
Authority:
United States: Federal Government
Study ID:
199/13923
NCT ID:
NCT00004465
Start Date:
July 1998
Completion Date:
Related Keywords:
- Hemolytic Uremic Syndrome
- E. coli infection
- bacterial infection
- hemolytic uremic syndrome
- immunologic disorders and infectious disorders
- rare disease
- renal and genitourinary disorders
- Hemolytic-Uremic Syndrome
- Azotemia
- Hemolysis
Name | Location |
|---|---|
| Bowman Gray School of Medicine | Winston Salem, North Carolina 27157 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
| New York Medical College | Valhalla, New York 10595 |
| St. Barnabas Medical Center | Livingston, New Jersey 07039 |
| North Shore University Hospital | Manhasset, New York 11030 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Children's Hospital of Denver | Denver, Colorado 80218 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
| Weill Medical College of Cornell University | New York, New York 10021 |
| Alfred I. Dupont Institute | Wilmington, Delaware 19899 |
| Maimonides Medical Center | Brooklyn, New York 11219 |
| Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Emory University School of Medicine | Atlanta, Georgia 30322 |
| Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
| Medical College of Georgia Hospital and Clinics | Augusta, Georgia 30912-3620 |
| Children's Hospital at St. Joseph's | Patterson, New Jersey 07503 |
| Jack D. Weiler Hospital of the Albert Einstein College of Medicine | Bronx, New York 10461 |
| Children's Hospital of Buffalo | Buffalo, New York 14222 |
| Ohio State University Children's Hospital | Columbus, Ohio 43205-2696 |
| University of Virginia | Charlottesville, Virginia 22908 |
| University of Wisconsin Children's Hospital | Madison, Wisconsin 53792-4108 |
