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

Escherichia Coli Infections Clinical Trial

— SHU O104 CUB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406288
• Other study ID #: CHUBX2011/26
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: November 19, 2012
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Azotemia
• Escherichia coli Infections
• Hemolysis
• Hemolytic-Uremic Syndrome
• Syndrome

Intervention

Other:
• HUS standard coverage care (including in ICU)
HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

Locations

Country	Name	City	State
France	Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	evaluate efficiency of therapeutic and diagnostic strategies		during patient hospitalization	Yes