search
Back to results

Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections (SERODIFF)

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serum
Stools
Saliva
Whole blood
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CH Annecy Genevois
  • Hôpital Jean Verdier
  • Hôpital Ambroise Paré
  • Hôpital Côte de Nacre
  • Hôpital Antoine Béclère
  • CHU de Dijon - Hôpital d'Enfants
  • Hôpital Raymond Poincaré
  • CHU de Grenoble
  • CHD Vendée
  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Hôpital Central de Nancy
  • Fondation Hospitalière Sainte-Marie
  • Groupe Hospitalier Paris Saint Joseph
  • Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache
  • Hôpital Lariboisière
  • Hôpital Saint Antoine
  • CHU de Reims - Hôpital Robert Debré
  • CHU de Rennes - Hôpital Pontchaillou
  • CHU de Rouen - Hôpital Charles Nicolle
  • CHU de Toulouse - Hôpital Purpan
  • CH de Tourcoing - Hôpital Gustave Dron
  • CHRU de Tours - Hôpital Bretonneau
  • CH de Valenciennes
  • Centre Hospitalier de Versailles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Case

Non-diarrheal control

Arm Description

Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins

Hospitalized patient and asymptomatic carrier of Clostridium Difficile

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Kinetics of antibody
The sera will be included in the analysis of the kinetics appearance of the immune response.
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.
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).
Risk factors
Matching of controls on sex, type of service, age and length of hospital stay.
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.

Full Information

First Posted
December 20, 2012
Last Updated
August 17, 2017
Sponsor
Versailles Hospital
Collaborators
Institut Pasteur, Sanofi Pasteur, a Sanofi Company, Saint Antoine University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01946750
Brief Title
Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections
Acronym
SERODIFF
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
Collaborators
Institut Pasteur, Sanofi Pasteur, a Sanofi Company, Saint Antoine University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Experimental
Arm Description
Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Arm Title
Non-diarrheal control
Arm Type
Other
Arm Description
Hospitalized patient and asymptomatic carrier of Clostridium Difficile
Intervention Type
Biological
Intervention Name(s)
Serum
Intervention Type
Biological
Intervention Name(s)
Stools
Intervention Type
Biological
Intervention Name(s)
Saliva
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Whole blood
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum antibody titers
Description
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).
Time Frame
J-6, J0
Secondary Outcome Measure Information:
Title
Kinetics of antibody
Description
The sera will be included in the analysis of the kinetics appearance of the immune response.
Time Frame
J-6, J0, J21, J90 and each recurrence
Title
Clinical evolution
Description
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.
Time Frame
J90
Title
Antibody titers for each antigen selected
Description
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).
Time Frame
J0
Title
Risk factors
Description
Matching of controls on sex, type of service, age and length of hospital stay.
Time Frame
3 months
Title
Molecular typing of Clostridium difficile strains
Description
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.
Time Frame
J0 and each recurrence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alban LE MONNIER, Microbiological coordinator
Organizational Affiliation
Versailles Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alix GREDER-BELAN, Clinical coordinator
Organizational Affiliation
Versailles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Annecy Genevois
City
Annecy
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
Country
France
Facility Name
Hôpital Ambroise Paré
City
Boulogne Billancourt
Country
France
Facility Name
Hôpital Côte de Nacre
City
Caen
Country
France
Facility Name
Hôpital Antoine Béclère
City
Clamart
Country
France
Facility Name
CHU de Dijon - Hôpital d'Enfants
City
Dijon
Country
France
Facility Name
Hôpital Raymond Poincaré
City
Garches
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
Country
France
Facility Name
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
City
Montpellier
Country
France
Facility Name
Hôpital Central de Nancy
City
Nancy
Country
France
Facility Name
Fondation Hospitalière Sainte-Marie
City
Paris
Country
France
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
Country
France
Facility Name
Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache
City
Paris
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
CHU de Reims - Hôpital Robert Debré
City
Reims
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse
Country
France
Facility Name
CH de Tourcoing - Hôpital Gustave Dron
City
Tourcoing
Country
France
Facility Name
CHRU de Tours - Hôpital Bretonneau
City
Tours
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Versailles
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs