Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance (DECLIC)

February 26, 2026 updated by: Fondation Hôpital Saint-Joseph

Clostridioides Difficile Infection: Prospective Cohort Analyzing CLInic Evolution and Bacterial Clearance

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Helene BEAUSSIER, PharmD, PhD
  • Phone Number: +33 144127883
  • Email: crc@ghpsj.fr

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Fondation Hôpital Saint-Joseph
        • Contact:
          • Assaf MIZRAHI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in a department of Hôpital Paris Saint-Joseph with microbiologically documented Clostridioides difficile infection or microbiologically documented recurrence of Clostridioides difficile infection, for whom treatment of Clostridioides difficile infection is to be initiated.

Description

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

Exclusion Criteria:

  • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Pregnant or breast-feeding patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of delay between diagnosis of CDI and early or late elimination of C. difficile
Time Frame: Month 2
This outcome corresponds to the kinetics of C. difficile elimination, and the time taken for the various microbiological tests (EIA, immunochromatography (ICT), culturomic and specific qPCR tests) detecting C. difficile in stools to become negative, from the day of diagnosis (i.e. before treatment was started), during the 10-day treatment period and after the end of treatment.
Month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confronting digestive microbiota dysbiosis with C. difficile elimination kinetics
Time Frame: Month 2
This outcome corresponds to the comparison in terms of number and type of digestive microbiota as a function of C. difficile elimination kinetics before treatment (at the time of diagnosis), at the end of 10 days of CDI treatment and after the end of treatment.
Month 2
Impact of antibiotics prescribed for the treatment of CDI after 10 days of treatment
Time Frame: Day 10
This outcome corresponds to the comparison in terms of number and type of diversity of digestive microbiota according to the type of anti-C. difficile antibiotic prescribed at the end of treatment, compared with the number and type of digestive observed at the time of diagnosis, i.e. before the start of treatment.
Day 10
Determination of the form in which C. difficile persists in the digestive microbiota during treatment and after the end of treatment until it is eliminated.
Time Frame: Month 2
This outcome corresponds to the type of the bacterial form (vegetative or spore-forming) that persists during and after ICD treatment by qPCR, Propidium monoazide - qPCR (PMA-qPCR) (viable or dead bacteria) and culturomics until digestive clearance of the bacteria.
Month 2
Evaluation of the colonic and salivary mucosal immune response of included patients, in relation to patient progress and C. difficile elimination kinetics.
Time Frame: Month 2
This outcome corresponds to the number of participants with a development of a C. difficile anti-toxin IgA response and correlation of colonic/salivary IgA levels after ICD with patient course (single, recurrent and severe forms) and C. difficile elimination kinetics.
Month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Assaf MIZRAHI, MD, Fondation Hôpital Saint-Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

November 17, 2026

Study Completion (Estimated)

January 17, 2027

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DECLIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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