Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance
NCT ID: NCT06030245
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-09-18
2025-11-17
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Clostridioides infection
The following procedures are specific to this test: 8 additional stool swabs (or Fecal Swab in the absence of stool output) to that of the initial diagnosis, plus four saliva swabs. Rectal swabs may cause anal irritation. The patient must also complete a stool collection form.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient deprived of liberty
* Patient under court protection
* Pregnant or breast-feeding patient
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Assaf MIZRAHI, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Fondation Hôpital Saint-Joseph
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Assaf MIZRAHI, MD
Role: primary
References
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Le Monnier A, Candela T, Mizrahi A, Bille E, Bourgeois-Nicolaos N, Cattoir V, Farfour E, Grall I, Lecointe D, Limelette A, Marcade G, Poilane I, Poupy P, Kansau I, Zahar JR, Pilmis B; GMC Group. One-day prevalence of asymptomatic carriage of toxigenic and non-toxigenic Clostridioides difficile in 10 French hospitals. J Hosp Infect. 2022 Nov;129:65-74. doi: 10.1016/j.jhin.2022.05.011. Epub 2022 May 28.
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Related Links
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Clostridioides difficile infection: guidance on management and treatment \[Internet\]. GOV.UK. 2022
Other Identifiers
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DECLIC
Identifier Type: -
Identifier Source: org_study_id