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Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4

NCT ID: NCT01406288

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemolytic-uremic Syndrome Escherichia Coli Infections

Keywords

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hemolytic-uremic syndrome shiga-toxin-producing E. Coli

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HUS epidemy in Bordeaux, E. coli of the O104H4 serotype

HUS standard coverage care (including in ICU)

Intervention Type OTHER

HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

Interventions

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HUS standard coverage care (including in ICU)

HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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christian COMBE, MD

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Christian COMBE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX2011/26

Identifier Type: -

Identifier Source: org_study_id