Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
- Conditions
- Clostridium Difficile Infection
- Registration Number
- NCT04567134
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- aged older than 19 years
- more than 3 times of unformed stools passage per day
- positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+)
- agree with informed consent
- less than 3 times of unformed stool passage per day
- use of oral metronidazole or vancomycin more than 24 hours before enrollment
- use of laxative before enrollment
- recurrent episode of CDI
- disagree with study protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of CDI through Oct 2020 to Dec 2021 Incidence of CDI among hospitalized adults per 100,000 patient\*days/10,000 patient\*admission in enrolled tertiary hospitals.
- Secondary Outcome Measures
Name Time Method mortality rate through Oct 2020 to May 2022 Proportion of CDI cases who died during the 60-day follow-up period
recurrence rate through Oct 2020 to May 2022 Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60