Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4
SHU O104 CUB
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 20, 2012
November 1, 2012
8 months
July 28, 2011
November 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
evaluate efficiency of therapeutic and diagnostic strategies
during patient hospitalization
Study Arms (1)
HUS epidemy in Bordeaux, E. coli of the O104H4 serotype
Interventions
HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption
Eligibility Criteria
dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).
You may qualify if:
- All patients with HUS concomitant to the outbreak linked to E. coli O104:H4
You may not qualify if:
- Patient not willing to participate or to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin
Bordeaux, 33076, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
christian COMBE, MD
University Hospital, Bordeaux
- PRINCIPAL INVESTIGATOR
Christian COMBE, MD
University Hospital, Bordeaux
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 20, 2012
Record last verified: 2012-11