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Phase 3
6 Months
18 Years
Not Enrolling
Both
Hemolytic Uremic Syndrome

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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 MedicineWinston Salem, North Carolina  27157
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
New York Medical CollegeValhalla, New York  10595
St. Barnabas Medical CenterLivingston, New Jersey  07039
North Shore University HospitalManhasset, New York  11030
University of Rochester Medical CenterRochester, New York  14642
Children's Hospital of DenverDenver, Colorado  80218
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Weill Medical College of Cornell UniversityNew York, New York  10021
Alfred I. Dupont InstituteWilmington, Delaware  19899
Maimonides Medical CenterBrooklyn, New York  11219
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Emory University School of MedicineAtlanta, Georgia  30322
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Medical College of Georgia Hospital and ClinicsAugusta, Georgia  30912-3620
Children's Hospital at St. Joseph'sPatterson, New Jersey  07503
Jack D. Weiler Hospital of the Albert Einstein College of MedicineBronx, New York  10461
Children's Hospital of BuffaloBuffalo, New York  14222
Ohio State University Children's HospitalColumbus, Ohio  43205-2696
University of VirginiaCharlottesville, Virginia  22908
University of Wisconsin Children's HospitalMadison, Wisconsin  53792-4108