Outbreak of Hemolytic Uremic Syndrome Linked to Escherich... | NCT01406288

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

NCT01406288

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Nov 20, 2012Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Hemolytic-uremic Syndrome
Escherichia Coli Infections

Interventions

HUS standard coverage care (including in ICU)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jul 28, 2011

First Submission Date that Met QC Criteria

Jul 28, 2011

First Posted Date

Aug 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2012

Last Update Posted Date

Nov 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HUS epidemy in Bordeaux, E. coli of the O104H4 serotype			Other: HUS standard coverage care (including in ICU)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HUS standard coverage care (including in ICU)	Other	HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption	HUS epidemy in Bordeaux, E. coli of the O104H4 serotype

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
evaluate efficiency of therapeutic and diagnostic strategies		during patient hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
christian COMBE, MD	University Hospital, Bordeaux	Study Director
Christian COMBE, MD	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin		Bordeaux		33076	France

Condition Browse Module

MeSH Terms

ID	Term
D006463	Hemolytic-Uremic Syndrome
D004927	Escherichia coli Infections

Ancestor Terms

ID	Term
D014511	Uremia
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007362	Intensive Care Units

Ancestor Terms

ID	Term
D006757	Hospital Units
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided