Clostridioides Difficile InfectionEpiCENCT07920627
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
An observational study of Clostridioides Difficile Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Clostridioides difficile infection (CDI) is the leading cause of infectious diarrhea among older adults. The epidemiology of community-acquired CDI, particularly among residents of long-term care facilities, remains poorly understood to this day. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 1 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: residents of nursing homes
Who may be able to join
- Men or women aged 65 or older
- Patients who have received information about the study and have not expressed objection
- Residents of the nursing home for more than 72 hours during the 12-month enrollment period
- No objection to the use of clinical and biological data in the event of an ICD.
Who cannot join
- A patient who is in the exclusion period of another research protocol at the time the informed consent form is obtained.
- A person who does not understand French
- No inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Clostridioides difficile infection (CDI) is the leading cause of infectious diarrhea among older adults. The epidemiology of community-acquired CDI, particularly among residents of long-term care facilities, remains poorly understood to this day. While numerous studies on the epidemiology, prevention, diagnosis, and treatment of CDI have been conducted in hospital settings, primary care often lags behind these advances. Limited access to diagnostic tests and treatment options, as well as insufficient resources allocated to preventing cross-transmission, are all factors that hinder the control of ICD in long-term care facilities. This will be the first French study on the epidemiology of ICD among nursing home residents, which can serve as a reference for implementing a multidisciplinary action plan and measuring its impact. This will be carried out as part of a city-hospital collaboration and will facilitate the creation of a healthcare network involving multiple healthcare providers, such as general practitioners working in nursing homes, clinical laboratories, pharmacies, dietitians and nutritionists, and the university hospital.
A better understanding of the epidemiology of ICD among residents in long-term care facilities and an assessment of professional practices related to ICD risk prevention should enable us to better target strategies for improving care while raising awareness among healthcare providers and public health policymakers. We therefore plan to optimize the impact of implementing a multidisciplinary action program aligned with the expectations of frontline practitioners regarding the reduction of the risk of ICD (training, prevention tools, diagnosis and treatment of ICD, appropriate use of antibiotics, nutritional counseling, prescribing probiotics, and establishing a coordinated care pathway for ICD). The implementation of this action program is expected to reduce the incidence rate of ICD, the recurrence rate, and antibiotic use in nursing homes, as well as the number of transfers to the hospital for ICD management.
- Conditions
- Clostridioides Difficile Infection
- Medical subject headings
- Clostridium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of ICD
- Probable C. difficile infection: diarrhea (>3 loose stools per 24 hours) within two months of taking an antibiotic or within 72 hours of hospitalization.
- Confirmed C. difficile infection: diarrhea AND detection of Clostridioides difficile toxins.
Measured: 24 MONTHS
Secondary outcomes (4)
the recurrence rate of C. difficile colitis
Measured: 24 MONTHS
Measuring the Use of Critical Antibiotics
Measured: 24 MONTHS
Measure the number of hospital transfers for ICD management.
Measured: 24 MONTHS
the prevalence of the main risk factors for ICD
Measured: 24MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cassir nadim, Principal investigator, assistance publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920627
- Sponsor's protocol ID
- RCAPHM26_0189
- Other IDs
- PADS26-262
- Acronym
- EpiCE
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
- ClinicalTrials.gov ID
- NCT07920627
- Acronym / sponsor ID
- EpiCE / RCAPHM26_0189
- Conditions
- Clostridioides Difficile Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clostridioides difficile infection (CDI) is the leading cause of infectious diarrhea among older adults. The epidemiology of community-acquired CDI, particularly among residents of long-term care facilities, remains poorly understood to this day. While numerous studies on the epidemiology, prevention, diagnosis, and treatment of CDI have been conducted in hospital settings, primary care often lags behind these advances. Limited access to diagnostic tests and treatment options, as well as insufficient resources allocated to preventing cross-transmission, are all factors that hinder the control of ICD in long-term care facilities. This will be the first French study on the epidemiology of ICD among nursing home residents, which can serve as a reference for implementing a multidisciplinary action plan and measuring its impact. This will be carried out as part of a city-hospital collaboration and will facilitate the creation of a healthcare network involving multiple healthcare providers, such as general practitioners working in nursing homes, clinical laboratories, pharmacies, dietitians and nutritionists, and the university hospital.
A better understanding of the epidemiology of ICD among residents in long-term care facilities and an assessment of professional practices related to ICD risk prevention should enable us to better target strategies for improving care while raising awareness among healthcare providers and public health policymakers. We therefore plan to optimize the impact of implementing a multidisciplinary action program aligned with the expectations of frontline practitioners regarding the reduction of the risk of ICD (training, prevention tools, diagnosis and treatment of ICD, appropriate use of antibiotics, nutritional counseling, prescribing probiotics, and establishing a coordinated care pathway for ICD). The implementation of this action program is expected to reduce the incidence rate of ICD, the recurrence rate, and antibiotic use in nursing homes, as well as the number of transfers to the hospital for ICD management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- residents of nursing homes
Key inclusion criteria (4 listed)
- Men or women aged 65 or older
- Patients who have received information about the study and have not expressed objection
- Residents of the nursing home for more than 72 hours during the 12-month enrollment period
- No objection to the use of clinical and biological data in the event of an ICD.
Key exclusion criteria (3 listed)
- A patient who is in the exclusion period of another research protocol at the time the informed consent form is obtained.
- A person who does not understand French
- No inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Rate of ICD
Time frame: 24 MONTHS
* Probable C. difficile infection: diarrhea (>3 loose stools per 24 hours) within two months of taking an antibiotic or within 72 hours of hospitalization. * Confirmed C. difficile infection: diarrhea AND detection of Clostridioides difficile toxins.
4 secondary outcomes
the recurrence rate of C. difficile colitis
Time frame: 24 MONTHS
Measuring the Use of Critical Antibiotics
Time frame: 24 MONTHS
Measure the number of hospital transfers for ICD management.
Time frame: 24 MONTHS
the prevalence of the main risk factors for ICD
Time frame: 24MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Related trials for Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
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A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
cassir nadim principal investigator
assistance publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridioides Difficile Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of ICD (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.