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Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04567134
Enrollment
500
Registered
2020-09-28
Start date
2020-10-01
Completion date
2022-12-31
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Keywords

clostridium difficile, incidence

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.

Interventions

None listed

Sponsors

Korean Center for Disease Control and Prevention
CollaboratorOTHER_GOV
Pfizer
CollaboratorINDUSTRY
Hanyang University Seoul Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of CDIthrough Oct 2020 to Dec 2021Incidence of CDI among hospitalized adults per 100,000 patient\*days/10,000 patient\*admission in enrolled tertiary hospitals.

Secondary

MeasureTime frameDescription
mortality ratethrough Oct 2020 to May 2022Proportion of CDI cases who died during the 60-day follow-up period
recurrence ratethrough Oct 2020 to May 2022Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60

Contacts

Primary ContactHyunjoo Pai, M.D., Ph.D.
paihyunjoo@gmail.com+82-2-2290-8356
Backup ContactJieun Kim, M.D., Ph.D.
quidam76@hanyang.ac.kr+82-31-560-2249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026