Informations générales (source: ClinicalTrials.gov)
Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile (PREVADIFF)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
novembre 2021
décembre 2024
29 juin 2024
Data on the seroprevalence of antibodies to Clostridioides difficile surface proteins and
toxins are scarce.
In 1983, Viscidi et al. showed that antibodies to C. difficile toxins A and B were
detected in 60 to 70% of an adult population. Two-thirds of the adults tested had a
serological trace, probably linked to a previous encounter with C. difficile.
One of the hypotheses raised would be that exposure to this pathogen occurs very early
and regularly throughout our lives. Indeed, in this study, antibodies to C. difficile
toxins were detected from early childhood and persisted over time even after 60 years.
The antibody response did not appear to vary with age or terrain. However, these results
were only qualitative and did not allow for inter-individual variations due to the
limitations of the techniques used at the time. Finally, in this work, it was important
to underline that the neutralizing character of the cytotoxic effect of toxins on cell
culture was not observed in all patients.
Since this seminal work, several studies have shown that the host immune response plays a
central role in the pathophysiology of C. difficile infections (CDI). In 2000, Kyne et
al. showed that after colonization with a toxigenic C. difficile strain, patients with
asymptomatic carriage had significantly higher serum levels of IgG directed against toxin
A than patients who developed disease. Subsequently, they also showed in 2001 that a
serum response directed against toxin A after a first episode of CDI was associated with
less recurrence. Finally, Leav et al. showed in 2010 that a serum response directed
against C. difficile toxin B was also associated with protection against recurrent forms.
Several studies have also suggested that the host immune response, this time directed
against colonization factors, could also play a major role in the evolution and prognosis
of CDI. In a previous study, investigators showed a significant difference in the level
of anti-SlpA antibodies (S-layer component) between CDI patients and control patients.
At the same time, the epidemiology of CDI has changed since 2003 due to the emergence of
a new epidemic and hypervirulent strain (PCR ribotype 027) producing a third toxin, the
binary toxin. The humoral response to this toxin remains poorly described to date.
On the basis of these numerous studies, new therapeutic immunization strategies (active
or passive) aimed at neutralizing the action of C. difficile toxins and colonization
factors have been or are being developed.
However, it remains to identify the patients likely to benefit from these innovative
strategies. This was the main objective of the SERODIFF study (currently being
finalized), which identified certain patient profiles in which no seroconversion or
isotype class switching of antibodies was observed following CDI. The absence of
neutralizing antibody production would seem to correlate with recurrent forms. Thus,
these patients would be those who could be eligible for a passive immunization strategy
such as the administration of anti-toxin B monoclonal antibodies, bezlotoxumab, recently
marketed in France.
In this study, investigators aim to evaluate the seroprevalence stratified by age group,
sex and by the main risk factors for CDI. Furthermore, the neutralizing and protective
effect of the detected antibodies against C. difficile virulence factors will be studied.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Alban LE MONNIER, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de SSR Pierre Chevalier - Toulon - France | Muriele PHILIP-DUTASTA, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Valenciennes - Valenciennes - France | Christian CATTOEN, MD | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées Sainte Anne, - Toulon - France | Frédéric Janvier, MD | Contact (sur clinicalTrials) | |||
| Hôpital Sainte-Marie Paris - 75014 - Paris - France | Bernard Durand Gasselin, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patient (≥ 18 years) hospitalized in targeted short-stay (MCO) and long-stay
(LTC) services for each of the three identified regions
- French-speaking patient
- Patient affiliated to the social security system or, failing that, to another health
insurance system
- Patient able to give free, informed and written consent
- Adult patient (≥ 18 years) hospitalized in targeted short-stay (MCO) and long-stay
(LTC) services for each of the three identified regions
- French-speaking patient
- Patient affiliated to the social security system or, failing that, to another health
insurance system
- Patient able to give free, informed and written consent
- History of blood transfusion, vascular filling, dialysis or polyvalent
immunoglobulin infusion.
- Patient deprived of liberty
- Patient under court protection
- Patient in an emergency situation
- Patients unable to give personal consent, including adults under guardianship