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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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

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.


Detailed Summary:
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: evaluate efficiency of therapeutic and diagnostic strategies [ Time Frame: during patient hospitalization ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: July 28, 2011
Date Started: July 2011
Date Completion:
Last Updated: November 19, 2012
Last Verified: November 2012