Hemolytic-uremic SyndromeSHU O104 CUBNCT01406288
Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4
An observational study of Hemolytic-uremic Syndrome and Escherichia Coli Infections, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hemolytic-uremic Syndrome, Escherichia Coli Infections
- What is being tested?
- HUS standard coverage care (including in ICU)
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).
Who may be able to join
- All patients with HUS concomitant to the outbreak linked to E. coli O104:H4
Who cannot join
- Patient not willing to participate or to sign informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin
Bordeaux, 33076
About this study
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
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.
Read more
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.
- Being tested
- HUS standard coverage care (including in ICU)
- Keywords
- hemolytic-uremic syndrome, shiga-toxin-producing E. Coli
- Medical subject headings
- Hemolytic-Uremic Syndrome, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUS standard coverage care (including in ICU)Other
HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption
| Study group | Role | What they receive |
|---|---|---|
| HUS epidemy in Bordeaux, E. coli of the O104H4 serotype | Not described Receives: Other: HUS standard coverage care (including in ICU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during patient hospitalization
Secondary outcomes (1)
evaluate efficiency of therapeutic and diagnostic strategies
Measured: during patient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic-uremic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- christian COMBE, MD, Study director, University Hospital, BordeauxChristian COMBE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406288
- Sponsor's protocol ID
- CHUBX2011/26
- Acronym
- SHU O104 CUB
- Status last verified
- Nov 2012
- First submitted
- 28 Jul 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01406288
- Acronym / sponsor ID
- SHU O104 CUB / CHUBX2011/26
- Keywords
- hemolytic-uremic syndrome, shiga-toxin-producing E. Coli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HUS epidemy in Bordeaux, E. coli of the O104H4 serotype | – | Other: HUS standard coverage care (including in ICU) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).
Key inclusion criteria (1 listed)
- All patients with HUS concomitant to the outbreak linked to E. coli O104:H4
Key exclusion criteria (1 listed)
- Patient not willing to participate or to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUS standard coverage care (including in ICU)HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption | Other | HUS epidemy in Bordeaux, E. coli of the O104H4 serotype |
Primary outcome
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.
1 secondary outcome
evaluate efficiency of therapeutic and diagnostic strategies
Time frame: during patient hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
christian COMBE, MD study director
University Hospital, Bordeaux
Christian COMBE, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic-uremic Syndrome and Escherichia Coli Infections, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.