Host Immune Response to Clostridium Difficile Infection (ICD)

Diarrhea Due to Clostridium Difficile Clinical Trial

— ICD  

Official title:

Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440438
• Other study ID #: 2013.806
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: October 5, 2016
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Due to Clostridium Difficile

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune response rate		up to 60 days after diagnosis	No