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

Clostridium Difficile Infection Clinical Trial

— SERODIFF  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946750
• Other study ID #: P11/51_SERODIFF
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: August 17, 2017
• Start date: December 2012
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria.

• Eligible patients (or their legal representatives) who are opposed to the use of their samples, the achieving samples and/or the longitudinal follow-up.

• Eligible patients who underwent plasmapheresis or treated with monoclonal antibodies to toxin A and B or immunoglobulins during the year preceding the episode of Clostridium Difficile Infection.

• Eligible patients but already included in the study for a recent infection with Clostridium Difficile or transferred to a second health facility for the same episode of Clostridium Difficile Infection.

• Eligible patients whose physicians responsible for the management refused participation in the study.

• Protected persons: pregnant women and children under the age of 18.

Secondarily be excluded the following cases:

• Patients for whom no sample has been achieved or retained by the laboratory of Medical Biology who participated in the diagnosis and monitoring of the patient.

• Hospitalized patients at the time of Clostridium Difficile Infection suspicion and diagnostic sample but released or transferred before rendering necessary microbiological results at baseline (J0 or J3).

• Matched control in a case excluded will be excluded.

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:

• Within a maximum period of six months after the inclusion of cases.

• Hospitalized in the same hospitalization service type as the case.

• With a duration of prior hospitalization at least as long as the time between admission and the corresponding case J0,

• Matched on sex and three age categories (18-40, 41-60 and> 60 years).

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).

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Infection

Intervention

Biological:
• Serum

• Stools

• 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.
• 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.

Locations

Country	Name	City	State
France	CH Annecy Genevois	Annecy
France	Hôpital Jean Verdier	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

Sponsors (4)

Lead Sponsor	Collaborator
Versailles Hospital	Institut Pasteur, Saint Antoine University Hospital, Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	J90
Secondary	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
Secondary	Risk factors	Matching of controls on sex, type of service, age and length of hospital stay.	3 months
Secondary	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