Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

NCT04567134

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+82-2-2290-8356

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Official Title Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
C. difficile isolates
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.

Condition Clostridium Difficile Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 23, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hyunjoo Pai, M.D., Ph.D.+82-2-2290-8356[email protected]
Contact: Jieun Kim, M.D., Ph.D.+82-31-560-2249[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04567134
Other Study ID Numbers HYUH 2020-06-046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hanyang University Seoul Hospital
Study Sponsor Hanyang University Seoul Hospital
Collaborators
  • Korean Center for Disease Control and Prevention
  • Pfizer
Investigators
Study Chair:Hyunjoo Pai, M.D., Ph.D.Hanyang University College of Medicine
PRS Account Hanyang University Seoul Hospital
Verification Date September 2020