Clostridium Difficile InfectionSERODIFFNCT01946750
Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections
A study testing Serum, Stools and Saliva in people with Clostridium Difficile Infection, run by Versailles Hospital at 24 sites in France.
Trial summary
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection. This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Serum, Stools and Saliva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 24 sitesFrance
- Study dates
- Dec 2012to Jun 2017
- 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 patients with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins or/and isolating in stools and by digestive biopsy a strain producer of Clostridium Difficile toxins.
- Patients for which a serum prior to the episode of Clostridium Difficile Infection, ideally as far as possible of the episode, but at least 6 days before the day of diagnosis (D0) will be available.
- Patients for which consent has been signed or by their legal representative by default.
- Patients for whom is found Clostridium Difficile Infection in their file surgical and those for whom Clostridium Difficile Infection is the reason for admission will be included in the study but will be subject of a separate analysis, and their witnesses.
Who cannot join
- Eligible patients for whom Clostridium Difficile Infection has been strongly suspected clinically but for which no microbiological confirmation will have been obtained.
- Eligible patients for whom no previous serum will have been recovered according to the criteria and conditions. The availability of a serum corresponding to the patient's admission is optional and can not be an exclusion criteria.
- Eligible patients (or their legal representatives) who are opposed to the use of their samples, the achieving samples and/or the longitudinal follow-up.
- Eligible patients who underwent plasmapheresis or treated with monoclonal antibodies to toxin A and B or immunoglobulins during the year preceding the episode of Clostridium Difficile Infection.
- Eligible patients but already included in the study for a recent infection with Clostridium Difficile or transferred to a second health facility for the same episode of Clostridium Difficile Infection.
- Eligible patients whose physicians responsible for the management refused participation in the study.
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- Protected persons: pregnant women and children under the age of 18.
- Secondarily be excluded the following cases:
- Patients for whom no sample has been achieved or retained by the laboratory of Medical Biology who participated in the diagnosis and monitoring of the patient.
- Hospitalized patients at the time of Clostridium Difficile Infection suspicion and diagnostic sample but released or transferred before rendering necessary microbiological results at baseline (J0 or J3).
- Matched control in a case excluded will be excluded.
- NON-DIARRHEAL CONTROL : Eligible patients are those who do not have diarrhea at the time of recruitment.
- To ensure that exposure to risks similar for cases and controls (hospitalization, usually care epidemic period, ...) will be recruited eligible patients according to the following criteria:
- Within a maximum period of six months after the inclusion of cases.
- Hospitalized in the same hospitalization service type as the case.
- With a duration of prior hospitalization at least as long as the time between admission and the corresponding case J0,
- Matched on sex and three age categories (18-40, 41-60 and> 60 years).
- The inclusion of these controls depends on the one hand signing an informed consent for participation in the study and secondly the lack clinical signs suggestive of Clostridium Difficile Infection at the time of inclusion and known history of Clostridium Difficile Infection in their medical records (one no-diarrheal control hospitalized (ND) for one case).
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
CH Annecy Genevois
Annecy
Hôpital Jean Verdier
Bondy
Hôpital Ambroise Paré
Boulogne-Billancourt
Hôpital Côte de Nacre
Caen
Hôpital Antoine Béclère
Clamart
CHU de Dijon - Hôpital d'Enfants
Dijon
Hôpital Raymond Poincaré
Garches
CHU de Grenoble
Grenoble
CHD Vendée
La Roche-sur-Yon
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier
Hôpital Central de Nancy
Nancy
Fondation Hospitalière Sainte-Marie
Paris
Groupe Hospitalier Paris Saint Joseph
Paris
Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache
Paris
Hôpital Lariboisière
Paris
Hôpital Saint Antoine
Paris
CHU de Reims - Hôpital Robert Debré
Reims
CHU de Rennes - Hôpital Pontchaillou
Rennes
CHU de Rouen - Hôpital Charles Nicolle
Rouen
CHU de Toulouse - Hôpital Purpan
Toulouse
CH de Tourcoing - Hôpital Gustave Dron
Tourcoing
CHRU de Tours - Hôpital Bretonneau
Tours
CH de Valenciennes
Valenciennes
Centre Hospitalier de Versailles
Versailles
About this study
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.
This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.
There are also building biological samples collections clinically documented: sera, stool and strains.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Serum, Stools, Saliva, Whole blood
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerumBiological
StoolsBiological
SalivaBiological
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum.
Whole bloodBiological
Optional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Hospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins Receives: Biological: Serum; Biological: Stools; Biological: Saliva; Biological: Whole blood |
| Non-diarrheal control | Other | Hospitalized patient and asymptomatic carrier of Clostridium Difficile Receives: Biological: Serum; Biological: Stools; Biological: Saliva; Biological: Whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum antibody titers
Consider the differential distribution of serum antibody titers, comparing experimental cases's sera prior episodes of Clostridium difficile infection (J-6) and the hospitalized controls's sera (J0).
Measured: J-6, J0
Secondary outcomes (5)
Kinetics of antibody
The sera will be included in the analysis of the kinetics appearance of the immune response.
Measured: J-6, J0, J21, J90 and each recurrence
Clinical evolution
Cases and controls : patients will be followed for 3 months to monitor the clinical evolution (or death) after the of Clostridium difficile infection episode and determine the occurrence of any recurrence up to 3 months after the diagnosis.
Measured: J90
Antibody titers for each antigen selected
Comparison of antibody titers for each antigen will be selected among different population groups formed : patients with Clostridium difficile infection, asymptomatic carriers patients, non-carriers patients including non-diarrheal and diarrheal (diarrhea due to other causes than Clostridium difficile infection).
Measured: J0
Risk factors
Matching of controls on sex, type of service, age and length of hospital stay.
Measured: 3 months
Molecular typing of Clostridium difficile strains
Molecular characterization of strains isolated from patients with Clostridium difficile infection (experimental cases) and recurrence, to confirm microbiologically the notion of recurrence after a previous episode or occurrence of a new episode following infection by a new strain of Clostridium difficile.
Measured: J0 and each recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Sanofi Pasteur, a Sanofi Company, Saint Antoine University Hospital
- Responsible party
- Principal investigator, Alban LE MONNIER, Versailles Hospital
- Investigators
- Alban LE MONNIER, Microbiological coordinator, Principal investigator, Versailles HospitalAlix GREDER-BELAN, Clinical coordinator, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946750
- Sponsor's protocol ID
- P11/51_SERODIFF
- Acronym
- SERODIFF
- Status last verified
- Aug 2017
- First submitted
- 20 Dec 2012
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections
- ClinicalTrials.gov ID
- NCT01946750
- Acronym / sponsor ID
- SERODIFF / P11/51_SERODIFF
- Conditions
- Clostridium Difficile Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Institut Pasteur, Sanofi Pasteur, a Sanofi Company, Saint Antoine University Hospital
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Sep 2013 (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.
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.
This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.
There are also building biological samples collections clinically documented: sera, stool and strains.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Biological: Serum, Biological: Stools, Biological: Saliva, Biological: Whole bloodHospitalized patient with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins |
| Non-diarrheal control | Other | Biological: Serum, Biological: Stools, Biological: Saliva, Biological: Whole bloodHospitalized patient and asymptomatic carrier of Clostridium Difficile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients with clinical signs of Clostridium Difficile Infection and specific detection in stools of Clostridium Difficile toxins or/and isolating in stools and by digestive biopsy a strain producer of Clostridium Difficile toxins.
- Patients for which a serum prior to the episode of Clostridium Difficile Infection, ideally as far as possible of the episode, but at least 6 days before the day of diagnosis (D0) will be available.
- Patients for which consent has been signed or by their legal representative by default.
- Patients for whom is found Clostridium Difficile Infection in their file surgical and those for whom Clostridium Difficile Infection is the reason for admission will be included in the study but will be subject of a separate analysis, and their witnesses.
Key exclusion criteria (18 listed)
- Eligible patients for whom Clostridium Difficile Infection has been strongly suspected clinically but for which no microbiological confirmation will have been obtained.
- Eligible patients for whom no previous serum will have been recovered according to the criteria and conditions. The availability of a serum corresponding to the patient's admission is optional and can not be an exclusion criteria.
- Eligible patients (or their legal representatives) who are opposed to the use of their samples, the achieving samples and/or the longitudinal follow-up.
- Eligible patients who underwent plasmapheresis or treated with monoclonal antibodies to toxin A and B or immunoglobulins during the year preceding the episode of Clostridium Difficile Infection.
- Eligible patients but already included in the study for a recent infection with Clostridium Difficile or transferred to a second health facility for the same episode of Clostridium Difficile Infection.
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 |
|---|---|---|
| Serum | Biological | Case, Non-diarrheal control |
| Stools | Biological | Case, Non-diarrheal control |
| SalivaOptional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum. | Biological | Case, Non-diarrheal control |
| Whole bloodOptional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response. | Biological | Case, Non-diarrheal control |
Primary outcome
Serum antibody titers
Time frame: J-6, J0
Consider the differential distribution of serum antibody titers, comparing experimental cases's sera prior episodes of Clostridium difficile infection (J-6) and the hospitalized controls's sera (J0).
5 secondary outcomes
Kinetics of antibody
Time frame: J-6, J0, J21, J90 and each recurrence
Clinical evolution
Time frame: J90
Antibody titers for each antigen selected
Time frame: J0
Risk factors
Time frame: 3 months
Molecular typing of Clostridium difficile strains
Time frame: J0 and each recurrence
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 22 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile Infection
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
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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. This study is not recruiting at the moment.
Alban LE MONNIER, Microbiological coordinator principal investigator
Versailles Hospital
Alix GREDER-BELAN, Clinical coordinator principal investigator
Versailles Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum, Stools and Saliva in people with Clostridium Difficile Infection, run by Versailles Hospital at 24 sites 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 18 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Serum antibody titers (time frame: J-6, J0). 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 22 Aug 2017.