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Completed

NCT Number: NCT01946750

Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

CASES :

Inclusion criteria

of the cases :

  • 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.

Exclusion criteria

of the cases :

  • 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.
  • 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).

Treatment and study plan

Serum

Biological

Stools

Biological

Saliva

Biological

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 Blood

Biological

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Kinetics of antibody

    Time frame: J-6, J0, J21, J90 and each recurrence

    The sera will be included in the analysis of the kinetics appearance of the immune response.

  2. Clinical evolution

    Time frame: J90

    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.

  3. Antibody titers for each antigen selected

    Time frame: J0

    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).

  4. Risk factors

    Time frame: 3 months

    Matching of controls on sex, type of service, age and length of hospital stay.

  5. Molecular typing of Clostridium difficile strains

    Time frame: J0 and each recurrence

    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.

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Collaborators

  • Institut Pasteur
  • Saint Antoine University Hospital
  • Sanofi Pasteur, a Sanofi Company

Registry information

Acronym: SERODIFF

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Sep 20, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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