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Clinical Trials/NCT01406288
NCT01406288
Completed
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country9 target enrollmentStarted: July 2011Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University Hospital, Bordeaux
Enrollment
9
Locations
1
Primary Endpoint
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

Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • evaluate efficiency of therapeutic and diagnostic strategies(during patient hospitalization)

Investigators

Sponsor
University Hospital, Bordeaux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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