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NCT04567134 Clinical Trial

Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Clostridium Difficile Infection Clinical Trial

Official title:
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04567134
Other study ID # HYUH 2020-06-046
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2022

Study information
Verified date September 2020
Source Hanyang University Seoul Hospital
Contact Hyunjoo Pai, M.D., Ph.D.
Phone +82-2-2290-8356
Email paihyunjoo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Hanyang University Seoul Hospital Korean Center for Disease Control and Prevention, Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary 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 mortality rate Proportion of CDI cases who died during the 60-day follow-up period through Oct 2020 to May 2022
Secondary recurrence rate Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60 through Oct 2020 to May 2022
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