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

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.

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Key information

Conditions

Hemolytic-Uremic Syndrome Anemia Anemia, Hemolytic Bacterial Infections Bacterial Infections and Mycoses Blood Platelet Disorders Cytopenia Enterobacteriaceae Infections Escherichia Coli Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Kidney Diseases Male Urogenital Diseases Thrombocytopenia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HUS standard coverage care (including in ICU)

Other

HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

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

Time frame: during patient hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: SHU O104 CUB

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Aug 1, 2011
Registry last updated: Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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