Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections

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.

Conditions

• Clostridium Difficile Infection

Interventions

BIOLOGICAL

Serum

BIOLOGICAL

Stools

BIOLOGICAL

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.

BIOLOGICAL

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.

Sponsors & Collaborators

• Institut Pasteur

  collaborator INDUSTRY

• Sanofi Pasteur, a Sanofi Company

  collaborator INDUSTRY

• Saint Antoine University Hospital

  collaborator OTHER

• Versailles Hospital

  lead OTHER

Principal Investigators

• Alban LE MONNIER, Microbiological coordinator · Versailles Hospital

• Alix GREDER-BELAN, Clinical coordinator · Versailles Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2016-06-30

Completion

2017-06-30

Countries

• France

Study Locations