Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
NCT04567134
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
+82-2-2290-8356
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
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 | 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:
Exclusion Criteria:
| ||||||||
| Sex/Gender |
| ||||||||
| Ages | 19 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
| ||||||||
| 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 |
| ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Hanyang University Seoul Hospital | ||||||||
| Study Sponsor | Hanyang University Seoul Hospital | ||||||||
| Collaborators |
| ||||||||
| Investigators |
| ||||||||
| PRS Account | Hanyang University Seoul Hospital | ||||||||
| Verification Date | September 2020 | ||||||||