Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4 (SHU O104 CUB)

November 19, 2012 updated by: University Hospital, Bordeaux

Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4 in Bordeaux Urban Area, June 2011: Evaluation of Diagnostic, Prognostic and Pathophysiological Data

The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the kidneys, brain, liver, pancreas, and skin.

Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in adults who are usually not involved in typical E. coli O157H7 HUS.

The aim of the present study is to gain knowledge on these different aspects of the HUS, including response to therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

Description

Inclusion Criteria:

  • All patients with HUS concomitant to the outbreak linked to E. coli O104:H4

Exclusion Criteria:

  • Patient not willing to participate or to sign informed consent

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HUS epidemy in Bordeaux, E. coli of the O104H4 serotype
Other: HUS standard coverage care (including in ICU)
HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve scientific knowledge on epidemic HUS in the context of an outbreak of E. coli O104:H4 HUS in the town of Bègles, urban area of Bordeaux, France
Time Frame: during patient hospitalization
This is an observational propspective study in which all data will be collected on all pertinent aspects of disease, including therapeutic regimens.
during patient hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluate efficiency of therapeutic and diagnostic strategies
Time Frame: during patient hospitalization
during patient hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Director: christian COMBE, MD, UH Bordeaux
  • Principal Investigator: Christian COMBE, MD, UH Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (ESTIMATE)

August 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 19, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2011/26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Escherichia Coli Infections

Clinical Trials on HUS standard coverage care (including in ICU)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe