Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections
SERODIFF
1 other identifier
interventional
240
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 22, 2017
August 1, 2017
3.5 years
December 20, 2012
August 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Kinetics of antibody
J-6, J0, J21, J90 and each recurrence
Clinical evolution
J90
Antibody titers for each antigen selected
J0
Risk factors
3 months
Molecular typing of Clostridium difficile strains
J0 and each recurrence
Study Arms (2)
Case
EXPERIMENTALHospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins
Non-diarrheal control
OTHERHospitalized patient and asymptomatic carrier of Clostridium Difficile
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Eligible patients for whom Clostridium Difficile Infection has been strongly suspected clinically but for which no microbiological confirmation will have been obtained.
- 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:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Versailles Hospitallead
- Institut Pasteurcollaborator
- Sanofi Pasteur, a Sanofi Companycollaborator
- Saint Antoine University Hospitalcollaborator
Study Sites (24)
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, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alban LE MONNIER, Microbiological coordinator
Versailles Hospital
- PRINCIPAL INVESTIGATOR
Alix GREDER-BELAN, Clinical coordinator
Versailles Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Microbiological coordinator
Study Record Dates
First Submitted
December 20, 2012
First Posted
September 20, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share