Multicenter, prospective cohort study on microbiota-defined and clinical risk factors for Clostridium difficile colonization and -associated disease in patient groups at risk

• Conditions: Enterocolitis due to Clostridium difficile; A04.7

• Registration Number: DRKS00005335
• Lead Sponsor: MHH OE6810

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-14
• Study Completion: 2016-06-30
• Results First Posted: 2019-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1521

Inclusion Criteria

Inpatients with underlying diseases causing in increased risk of C. difficile colonization/CDAD: a) malignant disease, b) s/p stem cell or solid organ transplantation, c) infiammatory bowel disease, d) hemodialysis, written informed consent

Exclusion Criteria

CDAD or suspected CDAD within 30 days prior to enrollment; diseases which prevent candidates to understand the nature and the consequences of the clinical trial; indications for protocol non-compliance

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with C. difficile colonization and -associated disease

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with CDAD, microbial pattern at baseline and at the final visit in colonized patients, microbial pattern at baseline and at the final visit in CDAD patients, disease course (severity, complications, recurrences) of CDAD, IgA and IgG repertoires in blood and intestinal mucosal samples