Informations générales (source: ClinicalTrials.gov)
Clostridioides Difficile Infection: Prospective Cohort Analyzing CLInic Evolution and Bacterial Clearance (DECLIC)
Observational
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
septembre 2023
novembre 2025
29 juin 2024
Clostridioides difficile (formerly Clostridium) is a bacterium found in the form of
spores (resistance form) in the environment to which patients may be exposed. This
bacterium used to belong to the Clostridium genus, but analysis of its 16S ribosomal RNA
in 2016 led to its being distinguished from it. Once the spore has been ingested, it can
germinate in vegetative form (the active form of the bacterium), taking on the appearance
of a Gram-positive bacillus that will colonize the digestive microbiota. This preliminary
stage of digestive colonization by the bacteria is facilitated by certain factors,
notably nasogastric probing, antacids, etc. Antibiotics, for their part, disrupt the
bacteria of the digestive microbiota (dysbiosis), thus facilitating the implantation of
C. difficile. Certain strains (known as toxigenic) will produce the main virulence
factors: toxins A (TcdA) and B (TcdB) ± a third toxin (binary toxin or CDT), and thus
cause the main clinical signs of digestive infection, particularly in patients with risk
factors for C. difficile infection (progressive cancer, immunodepression, etc.).
Clostridioides difficile infection (CDI) is characterized by variable clinical
presentations, ranging from simple watery diarrhea without colitis, which often resolves
spontaneously, to severe forms with complications such as pseudomembranous colitis,
intestinal perforation or septic shock, which have a very poor prognosis.
Management of this type of CDI relies mainly on the oral administration of
anti-clostridium difficile antibiotics such as fidaxomicin (FDX) or vancomycin (VAN) for
10 days, as recommended by the European ESCMID, British and American IDSA guidelines.
Oral metronidazole is recommended only in the absence of availability of the first two
molecules (community use). Despite this treatment, one of the main characteristics of CDI
is a high recurrence rate, which can reach 25% of cases. With FDX, recurrence rates
appear to be lower, especially as its administration regimen is optimized. Nevertheless,
its high cost is a barrier to its wider use.
In view of the high cost to the community of treating recurrences, and the reduced
quality of life of patients suffering from these recurrences, which are sometimes
multiple and highly incapacitating, reducing the occurrence of recurrences is a major
challenge. A better understanding of the factors leading to recurrence is therefore a
prerequisite for optimizing CDI prevention and treatment strategies.
The study of colonic mucosal immunity (aimed at quantifying IgA in stools) could also
contribute to a better understanding of patient progress.
All these issues surrounding CDI and its management justify the setting up of a
prospective cohort for the longitudinal follow-up of infected patients, enabling us to
study the digestive clearance of the bacteria according to various factors, notably the
digestive microbiota and the mucosal immune response.
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 | Assaf MIZRAHI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients over 18 years of age
- Patients hospitalized in a department of GH Paris Saint-Joseph with a
microbiologically documented Clostridioides difficile infection or a
microbiologically documented Clostridioides difficile recurrence.
- Patient to be treated for Clostridioides difficile infection
- French-speaking patient
- Patients who do not object to their participation in the study
- Patients over 18 years of age
- Patients hospitalized in a department of GH Paris Saint-Joseph with a
microbiologically documented Clostridioides difficile infection or a
microbiologically documented Clostridioides difficile recurrence.
- Patient to be treated for Clostridioides difficile infection
- French-speaking patient
- Patients who do not object to their participation in the study
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Pregnant or breast-feeding patient