Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
1 other identifier
observational
500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 28, 2020
September 1, 2020
1.2 years
September 23, 2020
September 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of CDI
Incidence of CDI among hospitalized adults per 100,000 patient\*days/10,000 patient\*admission in enrolled tertiary hospitals.
through Oct 2020 to Dec 2021
Secondary Outcomes (2)
mortality rate
through Oct 2020 to May 2022
recurrence rate
through Oct 2020 to May 2022
Eligibility Criteria
The patients who admitted at the tertiary hospitals in Korea and and diagnosed as Clostridioides difficile infection will be selected. The tertiary hospitals located in Seoul-si, Gyeonggi-do, Pusan-si, Daegu-si, Jeollanam-do, Jeollabuk-do, and Chungcheongbuk-do. These hospitals distributes all over the country.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanyang University Seoul Hospitallead
- Korean Center for Disease Control and Preventioncollaborator
- Pfizercollaborator
Biospecimen
C. difficile isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hyunjoo Pai, M.D., Ph.D.
Hanyang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
September 28, 2020
Study Start
October 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
September 28, 2020
Record last verified: 2020-09