Clostridium Difficile InfectionNCT04567134
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
An observational study of Clostridium Difficile Infection, run by Hanyang University Seoul Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
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.
- Conditions
- Clostridium Difficile Infection
- Keywords
- clostridium difficile, incidence
- Medical subject headings
- Clostridium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CDI
Incidence of CDI among hospitalized adults per 100,000 patient*days/10,000 patient*admission in enrolled tertiary hospitals.
Measured: through Oct 2020 to Dec 2021
Secondary outcomes (2)
mortality rate
Proportion of CDI cases who died during the 60-day follow-up period
Measured: through Oct 2020 to May 2022
recurrence rate
Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60
Measured: through Oct 2020 to May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention, Pfizer
- Responsible party
- Sponsor
- Investigators
- Hyunjoo Pai, M.D., Ph.D., Study chair, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567134
- Sponsor's protocol ID
- HYUH 2020-06-046
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
- ClinicalTrials.gov ID
- NCT04567134
- Acronym / sponsor ID
- HYUH 2020-06-046
- Conditions
- Clostridium Difficile Infection
- Keywords
- clostridium difficile, incidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention, Pfizer
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of CDI
Time frame: through Oct 2020 to Dec 2021
Incidence of CDI among hospitalized adults per 100,000 patient*days/10,000 patient*admission in enrolled tertiary hospitals.
2 secondary outcomes
mortality rate
Time frame: through Oct 2020 to May 2022
recurrence rate
Time frame: through Oct 2020 to May 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunjoo Pai, M.D., Ph.D. study chair
Hanyang University
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Hanyang University Seoul Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyunjoo Pai, M.D., Ph.D. (+82-2-2290-8356, paihyunjoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CDI (time frame: through Oct 2020 to Dec 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.