Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections
NCT ID: NCT01946750
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2012-12-31
2017-06-30
Brief Summary
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This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.
There are also building biological samples collections clinically documented: sera, stool and strains.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Case
Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Serum
Stools
Saliva
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum.
Whole blood
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response.
Non-diarrheal control
Hospitalized patient and asymptomatic carrier of Clostridium Difficile
Serum
Stools
Saliva
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum.
Whole blood
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response.
Interventions
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Serum
Stools
Saliva
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum.
Whole blood
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response.
Eligibility Criteria
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Inclusion Criteria
* Patients for which a serum prior to the episode of Clostridium Difficile Infection, ideally as far as possible of the episode, but at least 6 days before the day of diagnosis (D0) will be available.
* Patients for which consent has been signed or by their legal representative by default.
* Patients for whom is found Clostridium Difficile Infection in their file surgical and those for whom Clostridium Difficile Infection is the reason for admission will be included in the study but will be subject of a separate analysis, and their witnesses.
Exclusion Criteria
* Eligible patients (or their legal representatives) who are opposed to the use of their samples, the achieving samples and/or the longitudinal follow-up.
* Eligible patients who underwent plasmapheresis or treated with monoclonal antibodies to toxin A and B or immunoglobulins during the year preceding the episode of Clostridium Difficile Infection.
* Eligible patients but already included in the study for a recent infection with Clostridium Difficile or transferred to a second health facility for the same episode of Clostridium Difficile Infection.
* Eligible patients whose physicians responsible for the management refused participation in the study.
* Protected persons: pregnant women and children under the age of 18.
Secondarily be excluded the following cases:
* Patients for whom no sample has been achieved or retained by the laboratory of Medical Biology who participated in the diagnosis and monitoring of the patient.
* Hospitalized patients at the time of Clostridium Difficile Infection suspicion and diagnostic sample but released or transferred before rendering necessary microbiological results at baseline (J0 or J3).
* Matched control in a case excluded will be excluded.
NON-DIARRHEAL CONTROL : Eligible patients are those who do not have diarrhea at the time of recruitment.
To ensure that exposure to risks similar for cases and controls (hospitalization, usually care epidemic period, ...) will be recruited eligible patients according to the following criteria:
* Within a maximum period of six months after the inclusion of cases.
* Hospitalized in the same hospitalization service type as the case.
* With a duration of prior hospitalization at least as long as the time between admission and the corresponding case J0,
* Matched on sex and three age categories (18-40, 41-60 and\> 60 years).
The inclusion of these controls depends on the one hand signing an informed consent for participation in the study and secondly the lack clinical signs suggestive of Clostridium Difficile Infection at the time of inclusion and known history of Clostridium Difficile Infection in their medical records (one no-diarrheal control hospitalized (ND) for one case).
18 Years
ALL
No
Sponsors
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Institut Pasteur
INDUSTRY
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Saint Antoine University Hospital
OTHER
Versailles Hospital
OTHER
Responsible Party
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Alban LE MONNIER
Microbiological coordinator
Principal Investigators
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Alban LE MONNIER, Microbiological coordinator
Role: PRINCIPAL_INVESTIGATOR
Versailles Hospital
Alix GREDER-BELAN, Clinical coordinator
Role: PRINCIPAL_INVESTIGATOR
Versailles Hospital
Locations
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CH Annecy Genevois
Annecy, , France
Hôpital Jean Verdier
Bondy, , France
Hôpital Ambroise Paré
Boulogne-Billancourt, , France
Hôpital Côte de Nacre
Caen, , France
Hôpital Antoine Béclère
Clamart, , France
CHU de Dijon - Hôpital d'Enfants
Dijon, , France
Hôpital Raymond Poincaré
Garches, , France
CHU de Grenoble
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, , France
Hôpital Central de Nancy
Nancy, , France
Fondation Hospitalière Sainte-Marie
Paris, , France
Groupe Hospitalier Paris Saint Joseph
Paris, , France
Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache
Paris, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint Antoine
Paris, , France
CHU de Reims - Hôpital Robert Debré
Reims, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, , France
CHU de Toulouse - Hôpital Purpan
Toulouse, , France
CH de Tourcoing - Hôpital Gustave Dron
Tourcoing, , France
CHRU de Tours - Hôpital Bretonneau
Tours, , France
CH de Valenciennes
Valenciennes, , France
Centre Hospitalier de Versailles
Versailles, , France
Countries
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Other Identifiers
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P11/51_SERODIFF
Identifier Type: -
Identifier Source: org_study_id
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