Clostridium Difficile Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALSerum
BIOLOGICALStools
BIOLOGICALSaliva
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.
BIOLOGICALWhole 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.
Sponsors
Institut Pasteur
Sanofi Pasteur, a Sanofi Company
Saint Antoine University Hospital
Versailles Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
CASES : Inclusion criteria of the cases : * Hospitalized patients with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins or/and isolating in stools and by digestive biopsy a strain producer of Clostridium Difficile toxins. * 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
of the cases : * Eligible patients for whom Clostridium Difficile Infection has been strongly suspected clinically but for which no microbiological confirmation will have been obtained. * Eligible patients for whom no previous serum will have been recovered according to the criteria and conditions. The availability of a serum corresponding to the patient's admission is optional and can not be an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum antibody titers | J-6, J0 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evolution | J90 | 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. |
| Kinetics of antibody | J-6, J0, J21, J90 and each recurrence | The sera will be included in the analysis of the kinetics appearance of the immune response. |
| Antibody titers for each antigen selected | J0 | 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). |
| Risk factors | 3 months | Matching of controls on sex, type of service, age and length of hospital stay. |
| Molecular typing of Clostridium difficile strains | J0 and each recurrence | 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. |
Countries
France
Outcome results
None listed