Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region

Completed

• Conditions: Clostridium Difficile Infection

• Registration Number: NCT01560832
• Lead Sponsor: Yonsei University

Brief Summary

Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards
• PCR-diagnosed CDI while at the hospital
• Informed consent has been obtained from patients as required by local requirements

Exclusion Criteria

• Age < 20 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients	every 5 days after consented to enroll the exam	A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools \[diarrhea\] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital.; The study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100).

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of