Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region
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.
Clostridium Difficile Infection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients [ Time Frame: every 5 days after consented to enroll the exam ] [ Designated as safety issue: No ]
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).
|Study Start Date:||December 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Laboratory (PCR)-confirmed C.difficile infection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560832
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|