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| Name | Class |
|---|---|
| Institut Pasteur | INDUSTRY |
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| Saint Antoine University Hospital | OTHER |
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Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins |
|
| Non-diarrheal control | Other | Hospitalized patient and asymptomatic carrier of Clostridium Difficile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum | Biological |
| ||
| Stools |
| Measure | Description | Time Frame |
|---|---|---|
| Serum antibody titers | Consider the differential distribution of serum antibody titers, comparing experimental cases's sera prior episodes of Clostridium difficile infection (J-6) and the hospitalized controls's sera (J0). | J-6, J0 |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics of antibody | The sera will be included in the analysis of the kinetics appearance of the immune response. | J-6, J0, J21, J90 and each recurrence |
| Clinical evolution | Cases and controls : patients will be followed for 3 months to monitor the clinical evolution (or death) after the of Clostridium difficile infection episode and determine the occurrence of any recurrence up to 3 months after the diagnosis. |
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CASES :
Inclusion criteria of the cases :
Exclusion criteria of the cases :
Secondarily be excluded the following cases:
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Alban LE MONNIER, Microbiological coordinator | Versailles Hospital | Principal Investigator |
| Alix GREDER-BELAN, Clinical coordinator | Versailles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Annecy | France | ||||
| Hôpital Jean Verdier |
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|
| Saliva | Biological | 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 | Biological | 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. |
|
| J90 |
| Antibody titers for each antigen selected | Comparison of antibody titers for each antigen will be selected among different population groups formed : patients with Clostridium difficile infection, asymptomatic carriers patients, non-carriers patients including non-diarrheal and diarrheal (diarrhea due to other causes than Clostridium difficile infection). | J0 |
| Risk factors | Matching of controls on sex, type of service, age and length of hospital stay. | 3 months |
| Molecular typing of Clostridium difficile strains | Molecular characterization of strains isolated from patients with Clostridium difficile infection (experimental cases) and recurrence, to confirm microbiologically the notion of recurrence after a previous episode or occurrence of a new episode following infection by a new strain of Clostridium difficile. | J0 and each recurrence |
| 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 |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003672 | Defecation |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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