Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Difficile Infection

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanyang University Seoul Hospital
• Collaborators: Pfizer; Korean Center for Disease Control and Prevention
• Investigators: Study Chair: Hyunjoo Pai, M.D., Ph.D., Hanyang University College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: incidence; clostridium difficile
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: HYUH 2020-06-046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No