Diarrhea Due to Clostridium DifficileICDNCT02440438
Host Immune Response to Clostridium Difficile Infection (ICD)
A study testing Blood sampling in people with Diarrhea Due to Clostridium Difficile, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea Due to Clostridium Difficile
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized
- Suffering from diarrhea related to C. difficile
- Confirmed diagnosis of CDI
- Informed consent by the patient
- Affiliated to the social security regime
Who cannot join
- Out-patient
- No confirmed diagnosis of CDI
- Decline of participation
- Patient not affiliated to the social security regime
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot
Lyon, 69437
About this study
Official title: Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A\&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.
- Conditions
- Diarrhea Due to Clostridium Difficile
- Being tested
- Blood sampling
- Keywords
- Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Clostridium difficile infection | Experimental | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune response rate
Measured: up to 60 days after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diarrhea Due to Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440438
- Sponsor's protocol ID
- 2013.806
- Acronym
- ICD
- Status last verified
- Dec 2025
- First submitted
- 7 May 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
P Vanhems. "État des lieux des pratiques de prise en charge des ICD en France - Réseau DIFTEC" - JNI 2017 (symposium).
"Incidence des infections à C. difficile" - communication (HCL Lyon, services d'Hygiène & Microbiologie). Auteurs indiqués : P. Vanhems, L. Oltra, M. Hulin, F. Vandenesch, O. Dauwalder.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response
- ClinicalTrials.gov ID
- NCT02440438
- Acronym / sponsor ID
- ICD / 2013.806
- Conditions
- Diarrhea Due to Clostridium Difficile
- Keywords
- Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A\&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium difficile infection | Experimental | Biological: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized
- Suffering from diarrhea related to C. difficile
- Confirmed diagnosis of CDI
- Informed consent by the patient
- Affiliated to the social security regime
Key exclusion criteria (4 listed)
- Out-patient
- No confirmed diagnosis of CDI
- Decline of participation
- Patient not affiliated to the social security regime
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge | Biological | Clostridium difficile infection |
Primary outcome
immune response rate
Time frame: up to 60 days after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationP Vanhems. "État des lieux des pratiques de prise en charge des ICD en France - Réseau DIFTEC" - JNI 2017 (symposium).
- Results publication"Incidence des infections à C. difficile" - communication (HCL Lyon, services d'Hygiène & Microbiologie). Auteurs indiqués : P. Vanhems, L. Oltra, M. Hulin, F. Vandenesch, O. Dauwalder.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Diarrhea Due to Clostridium Difficile, run by Hospices Civils de Lyon 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
immune response rate (time frame: up to 60 days after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440438, which also lists 2 linked publications.
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 19 Dec 2025.