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Host Immune Response to Clostridium Difficile Infection (ICD)

NCT ID: NCT02440438

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea Due to Clostridium Difficile

Keywords

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Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clostridium difficile infection

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

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

Interventions

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Blood sampling

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Hospitalized
* Suffering from diarrhea related to C. difficile
* Confirmed diagnosis of CDI
* Informed consent by the patient
* Affiliated to the social security regime

Exclusion Criteria

* Out-patient
* No confirmed diagnosis of CDI
* Decline of participation
* Patient not affiliated to the social security regime
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

References

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P Vanhems. "État des lieux des pratiques de prise en charge des ICD en France - Réseau DIFTEC" - JNI 2017 (symposium).

Reference Type RESULT

"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.

Reference Type RESULT

Other Identifiers

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2013.806

Identifier Type: -

Identifier Source: org_study_id