Actively Recruiting

Age: 18Years +
All Genders
ID06030245

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

Led by Fondation Hôpital Saint-Joseph · Updated on 2026-03-02

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Clostridioides difficile infection (CDI) is caused by a bacterium that can colonize the digestive system, especially in patients with risk factors like cancer or weakened immune systems. This infection can range from mild diarrhea to severe complications such as colitis or septic shock. Treatments typically include oral antibiotics like fidaxomicin or vancomycin, but recurrent infections are common and affect patients' quality of life. This research aims to better understand the factors leading to recurrence and improve prevention and treatment strategies. This observational study follows patients diagnosed with CDI over time to analyze how the bacteria clear from the digestive system. Patients will provide additional stool and saliva samples to study digestive microbiota changes and immune responses during and after treatment. The study tracks bacterial elimination and immune markers to gain insight into patient progress and infection dynamics. Participants will be asked to provide stool and saliva samples at various times, complete stool collection forms, and undergo monitoring for bacterial clearance and immune response. Researchers will measure how long it takes for the bacteria to clear after diagnosis and treatment, the impact of antibiotics, and the role of the immune system. The study helps inform better management of CDI and its recurrent forms, with participation lasting up to two months from diagnosis.

CONDITIONS

Brief Title

Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Hospitalized with microbiologically confirmed Clostridioides difficile infection or recurrence
  • Patient is receiving treatment for Clostridioides difficile infection
  • French-speaking patient
  • Patients who do not object to participating in the study
Not Eligible

You will not qualify if you...

  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection
  • Pregnant or breastfeeding patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 months

Participants provide stool and saliva samples to monitor Clostridioides difficile infection and bacterial clearance. This includes 8 stool or fecal swabs and 4 saliva swabs, along with completion of a stool collection form.

Multiple sample collections over the study period

Trial Site Locations

Total: 1 location

1

Fondation Hôpital Saint-Joseph

Paris, France, 75014

Actively Recruiting

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Research Team

A

Assaf MIZRAHI, MD

H

Helene BEAUSSIER, PharmD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults.

Stuart Johnson, Valéry Lavergne, Andrew M Skinner...

https://pubmed.ncbi.nlm.nih.gov/34164674

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults.

Joffrey van Prehn, Elena Reigadas, Erik H Vogelzang...

https://pubmed.ncbi.nlm.nih.gov/34678515

Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial.

Oliver A Cornely, Derrick W Crook, Roberto Esposito...

https://pubmed.ncbi.nlm.nih.gov/22321770

Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial.

Benoit Guery, Francesco Menichetti, Veli-Jukka Anttila...

https://pubmed.ncbi.nlm.nih.gov/29273269

Cost-effectiveness analysis on the use of fidaxomicin and vancomycin to treat Clostridium difficile infection in France.

Maureen Watt, Aurélien Dinh, Alban Le Monnier...

https://pubmed.ncbi.nlm.nih.gov/28299963

Efficacy of alternative fidaxomicin dosing regimens for treatment of simulated Clostridium difficile infection in an in vitro human gut model.

C H Chilton, G S Crowther, S L Todhunter...

https://pubmed.ncbi.nlm.nih.gov/26078392

One-day prevalence of asymptomatic carriage of toxigenic and non-toxigenic Clostridioides difficile in 10 French hospitals.

A Le Monnier, T Candela, A Mizrahi...

https://pubmed.ncbi.nlm.nih.gov/35640734