Host Immune Response to Clostridium Difficile Infection (ICD)
ICD
Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response
1 other identifier
interventional
56
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedDecember 19, 2025
December 1, 2025
2.6 years
May 7, 2015
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
immune response rate
up to 60 days after diagnosis
Study Arms (1)
Clostridium difficile infection
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Hospitalized
- Suffering from diarrhea related to C. difficile
- Confirmed diagnosis of CDI
- Informed consent by the patient
- Affiliated to the social security regime
You may not qualify if:
- Out-patient
- No confirmed diagnosis of CDI
- Decline of participation
- Patient not affiliated to the social security regime
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot
Lyon, 69437, France
Related Publications (2)
P Vanhems. "État des lieux des pratiques de prise en charge des ICD en France - Réseau DIFTEC" - JNI 2017 (symposium).
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 12, 2015
Study Start
January 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
December 19, 2025
Record last verified: 2025-12