Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Hanyang University Seoul Hospital

Status: Unknown

Conditions: Clostridium Difficile Infection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04567134

HYUH 2020-06-046

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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