Epidemiology of Clostridium difficile infection in Japan

Epidemiology of Clostridium difficile infection in Japan - CDI-Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015336

Enrollment

1000

Registered

2014-10-03

Start date

2014-05-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium difficile infection (CDI)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who newly develope clinically significant diarrhea in the study wards and who provide written consent are eligible for inclusion.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1. Incidence of CDI Incidence of CDI will be measured as the number of positive C. difficile tests (by any test) per 10,000 patient-days (pd) in the study wards Attempts will be made to assess the relationship between incidence of CDI and (a) testing density (measured as the number of test per 10,000 pd) (b) the C. difficile laboratory tests used (c) the ward/population type 2. CDI population characteristics, management and outcome CDI population characteristics will be described and compared to the non CDI population The management of CDI will be described together with the status of the patients 60 days after the onset of the disease to assess morbidity/mortality. The 60 days outcome of CDI patient will be compared to the one of non CDI patients to assess CDI related morbidity 3. Performance of NAAT, toxigenic culture and the standard laboratory tests performed in hospitals in Japan Test results will be compared across the 3 C. difficile tests performed (in hospital laboratory or in NIID). Characteristics of individual with discrepant results and their 60 days post CDI outcome will also be described. 4. Molecular epidemiology of CDI and antibiotic susceptibility of C. difficile recovered from hospitalized patients in Japan Typing analysis and antibiotic susceptibility testing will be performed and described.	—

Measure

Time frame

1. Incidence of CDI Incidence of CDI will be measured as the number of positive C. difficile tests (by any test) per 10,000 patient-days (pd) in the study wards Attempts will be made to assess the relationship between incidence of CDI and (a) testing density (measured as the number of test per 10,000 pd) (b) the C. difficile laboratory tests used (c) the ward/population type 2. CDI population characteristics, management and outcome CDI population characteristics will be described and compared to the non CDI population The management of CDI will be described together with the status of the patients 60 days after the onset of the disease to assess morbidity/mortality. The 60 days outcome of CDI patient will be compared to the one of non CDI patients to assess CDI related morbidity 3. Performance of NAAT, toxigenic culture and the standard laboratory tests performed in hospitals in Japan Test results will be compared across the 3 C. difficile tests performed (in hospital laboratory or in NIID). Characteristics of individual with discrepant results and their 60 days post CDI outcome will also be described. 4. Molecular epidemiology of CDI and antibiotic susceptibility of C. difficile recovered from hospitalized patients in Japan Typing analysis and antibiotic susceptibility testing will be performed and described.

—

Countries

Japan

Contacts

Public ContactHaru Kato

National Institute of Infectious Diseases Department of Bacteriology II

cato@nih.go.jp+81-42-561-0771

Outcome results