Suspended

Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated

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What is being tested

SYNSORB Pk

+ Placebo

Drug
Who is being recruted

Cytopenia+25

+ Anemia

+ Anemia, Hemolytic

From 6 Months to 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 1997
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: June 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 27, 1997

Actual date on which the first participant was enrolled.

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.

NCT00004465
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: June 1, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

145 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAnemiaAnemia, HemolyticBacterial Infections and MycosesBlood Platelet DisordersEnterobacteriaceae InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesInfectionsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombocytopeniaUremiaUrologic DiseasesGram-Negative Bacterial InfectionsDisease AttributesFemale Urogenital DiseasesMale Urogenital DiseasesThrombotic MicroangiopathiesUrogenital DiseasesBacterial InfectionsCommunicable DiseasesEscherichia coli InfectionsHemolytic-Uremic SyndromeImmune System DiseasesRare Diseases

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Oral Shiga toxin-binding agent (500 mg/kg/day)

Group II

Placebo
Cornmeal placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Children's Hospital of Denver

Denver, United StatesOpen Children's Hospital of Denver in Google Maps

Alfred I. Dupont Institute

Wilmington, United States

Emory University School of Medicine

Atlanta, United States

Medical College of Georgia Hospital and Clinics

Augusta, United States
Suspended27 Study Centers