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Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4 (SHU O104 CUB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01406288
First received: July 28, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Hemolytic-uremic Syndrome
Escherichia Coli Infections
 Other: HUS standard coverage care (including in ICU)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • evaluate efficiency of therapeutic and diagnostic strategies [ Time Frame: during patient hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HUS epidemy in Bordeaux, E. coli of the O104H4 serotype Other: HUS standard coverage care (including in ICU)
HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406288

Locations
France
Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Director: christian COMBE, MD UH Bordeaux
Principal Investigator: Christian COMBE, MD UH Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01406288     History of Changes
Other Study ID Numbers: CHUBX2011/26
Study First Received: July 28, 2011
Last Updated: November 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
hemolytic-uremic syndrome
shiga-toxin-producing E. Coli

Additional relevant MeSH terms:
Escherichia coli Infections
Hemolytic-Uremic Syndrome
Azotemia
Hemolysis
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Uremia
Kidney Diseases
 Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013