NCT01946750

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Versailles Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-06-01
• Completion: 2017-06-01
• First posted: 2013-09-20
• Last updated: 2017-08-22

Locations

24 sites across 1 country: France