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

Completed

• Conditions: Hemolytic-uremic Syndrome; Escherichia Coli Infections
• Interventions: Other: HUS standard coverage care (including in ICU)

• Registration Number: NCT01406288
• Lead Sponsor: University Hospital, Bordeaux

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 Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HUS epidemy in Bordeaux, E. coli of the O104H4 serotype	HUS standard coverage care (including in ICU)	-

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
evaluate efficiency of therapeutic and diagnostic strategies	during patient hospitalization

Trial Locations

Locations (1)

Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin; 🇫🇷 Bordeaux, France