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CompletedNCT01406288SHU O104 CUBUpdated Nov 20, 2012

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

An observational study in Hemolytic-uremic Syndrome and Escherichia Coli Infections, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2012-11-20.

Sponsored by University Hospital, Bordeaux · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemolytic-uremic Syndrome
  • Escherichia Coli Infections

Keywords

  • hemolytic-uremic syndrome
  • shiga-toxin-producing E. Coli
03

In context

Hemolytic-Uremic Syndrome

28 studies on the registry are indexed under Hemolytic-Uremic Syndrome; 7 are open to participants now.

This study's enrollment of 9 is below the median of 50 across 13 observational studies indexed under Hemolytic-Uremic Syndrome.

Browse Hemolytic-Uremic Syndrome studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 807 studies on the registry; 198 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with HUS concomitant to the outbreak linked to E. coli O104:H4

Exclusion criteria

Exclusion Criteria:

  • Patient not willing to participate or to sign
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)

Groups and cohorts

  • HUS epidemy in Bordeaux, E. coli of the O104H4 serotype

    Other: HUS standard coverage care (including in ICU)

Interventions

  • OtherHUS standard coverage care (including in ICU)

    HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption

06

What researchers measure

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.

    Time frame: during patient hospitalization

Secondary outcomes

  1. evaluate efficiency of therapeutic and diagnostic strategies

    Time frame: during patient hospitalization

07

Study locations

1 site
  • Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin
    Bordeaux, 33076, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2011
First posted
Aug 1, 2011
Start
Jul 2011
Primary completionActual
Mar 2012
CompletionActual
Mar 2012
Last update
Nov 20, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01406288
Responsible party
Sponsor
First posted
Aug 1, 2011
Start date
Jul 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Nov 20, 2012

Study contacts

christian COMBE, MD
study director · UH Bordeaux
Christian COMBE, MD
principal investigator · UH Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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