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OpenTrials
Completed

NCT Number: NCT02440438

Host Immune Response to Clostridium Difficile Infection (ICD)

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.

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Key information

Conditions

Diarrhea Due to Clostridium Difficile Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Blood sampling

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

Primary outcomes

  1. immune response rate

    Time frame: up to 60 days after diagnosis

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ICD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Dec 19, 2025

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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