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

Not Applicable

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Biological: Serum; Biological: Stools; Biological: Saliva; Biological: Whole blood

• Registration Number: NCT01946750
• Lead Sponsor: Versailles Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2016-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Stools	Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Non-diarrheal control	Saliva	Hospitalized patient and asymptomatic carrier of Clostridium Difficile
Case	Serum	Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Case	Whole blood	Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Non-diarrheal control	Stools	Hospitalized patient and asymptomatic carrier of Clostridium Difficile
Case	Saliva	Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Non-diarrheal control	Whole blood	Hospitalized patient and asymptomatic carrier of Clostridium Difficile
Non-diarrheal control	Serum	Hospitalized patient and asymptomatic carrier of Clostridium Difficile

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (24)

Hôpital Côte de Nacre; 🇫🇷 Caen, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

CHU de Reims - Hôpital Robert Debré; 🇫🇷 Reims, France

CHU de Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHRU de Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

CH de Tourcoing - Hôpital Gustave Dron; 🇫🇷 Tourcoing, France

Hôpital Central de Nancy; 🇫🇷 Nancy, France

CHU de Dijon - Hôpital d'Enfants; 🇫🇷 Dijon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CH Annecy Genevois; 🇫🇷 Annecy, France

Hôpital Jean Verdier; 🇫🇷 Bondy, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne Billancourt, France

Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache; 🇫🇷 Paris, France

Hôpital Raymond Poincaré; 🇫🇷 Garches, France

CHD Vendée; 🇫🇷 La Roche Sur Yon, France

Fondation Hospitalière Sainte-Marie; 🇫🇷 Paris, France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHU de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Lariboisière; 🇫🇷 Paris, France

CHU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse, France

CH de Valenciennes; 🇫🇷 Valenciennes, France

Centre Hospitalier de Versailles; 🇫🇷 Versailles, France

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, France