UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015336
Receipt number R000017822
Scientific Title Epidemiology of Clostridium difficile infection in Japan
Date of disclosure of the study information 2014/10/03
Last modified on 2019/10/23 14:36:05

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Basic information

Public title

Epidemiology of Clostridium difficile infection in Japan

Acronym

CDI-Japan

Scientific Title

Epidemiology of Clostridium difficile infection in Japan

Scientific Title:Acronym

CDI-Japan

Region

Japan


Condition

Condition

Clostridium difficile infection (CDI)

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. To determine the incidence of CDI in selected hospitals in Japan
2. To describe CDI population characteristics, management and outcome
3. To compare performance of nucleic acid amplification test (NAAT), toxigenic culture and the standard laboratory tests used in Japanese hospitals
4. To describe molecular epidemiology of CDI in Japan and antibiotic resistance of C. difficile isolates

Basic objectives2

Others

Basic objectives -Others

Epidemiology

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

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.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

None

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Haru
Middle name
Last name Kato

Organization

National Institute of Infectious Diseases

Division name

Department of Bacteriology II

Zip code

2080011

Address

Gakuen 4-7-1, Musashimurayama, Tokyo 208-0011, Japan

TEL

+81-42-561-0771

Email

cato@nih.go.jp


Public contact

Name of contact person

1st name Haru
Middle name
Last name Kato

Organization

National Institute of Infectious Diseases

Division name

Department of Bacteriology II

Zip code

2080011

Address

Gakuen 4-7-1, Musashimurayama, Tokyo 208-0011, Japan

TEL

+81-42-561-0771

Homepage URL


Email

cato@nih.go.jp


Sponsor or person

Institute

National Institute of Infectious Diseases

Institute

Department

Personal name



Funding Source

Organization

Sanofi Pasteur

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

France


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Institute of Infectious Diseases

Address

Toyama 1-23-1, Shinjuku, Tokyo, Japan

Tel

03-5285-1111

Email

not available


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

八戸市立市民病院(青森県)
国立病院機構東京医療センター(東京都)
亀田総合病院(千葉県)
東京ベイ・浦安市川医療センター(千葉県)
豊川市民病院(愛知県)
東海中央病院(岐阜県)
国立病院機構刀根山病院(大阪府)
奈良県立医科大学附属病院(奈良県)
国立病院機構呉医療センター、中国がんセンター(広島県)
下関市立市民病院(山口県)
産業医科大学病院(福岡県)
沖縄県立南部医療センター・こども医療センター(沖縄県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 03 Day


Related information

URL releasing protocol

Not applicable

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/abs/pii/S1075996419300460?via%3Dihub

Number of participants that the trial has enrolled

566

Results

The overall incidence of CDI was 7.4/10,000 patient-days, and the testing frequency and CDI incidence rate were highly correlated. Numerous patients with CDI are being overlooked due to inadequate testing in Japan. Risk factors for CDI in Japan were similar to those identified in the US and Europe. The analytical sensitivities of NAAT and GDH-algorithm to detect toxigenic C. difficile were lower than most previous reports. Also, this study found low PPV of EIAs for toxins.

Results date posted

2019 Year 10 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A prospective cohort study of Clostridioides difficile infection (CDI) was conducted from May 12, 2014 to May 11, 2015 at 12 medical facilities (20 wards) located throughout 11 prefectures in Japan. Stool specimens were collected from patients 18 years of age or older with clinically significant diarrhea (CSD), who provided consent to participate. CSD was defined by one of the following conditions; 1) at least 3 diarrheal bowel movements (Bristol stool chart grade 6-7) in the previous 24 hours, or a diarrheal bowel movement with abdominal pain and/or cramping; 2) among patients with pre-existing chronic diarrhea, an increase of >= 3 diarrheal stools compared with the usual diarrheal frequency; 3) or the same frequency of diarrhea with new or worsening abdominal pain and/or cramping. CDI was defined by positive result on enzyme immunoassay for toxins A/B (EIA), nucleic acid amplification test for the toxin B gene (NAAT) or toxigenic culture (TC).

Participant flow

Of the 636 CSD episodes in 566 patients enrolled, 173 (27.2%) met study criteria for CDI. Eleven patients had multiple CDI episodes, three of whom had a new episode while eight experienced a recurrence. Of the 566 patients, a total of 152 patients received the diagnosis of CDI at the first enrollment.

Adverse events

Not applicable

Outcome measures

Not applicable

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 03 Month 21 Day

Date of IRB

2013 Year 03 Month 14 Day

Anticipated trial start date

2014 Year 05 Month 12 Day

Last follow-up date

2016 Year 07 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 10 Month 03 Day


Other

Other related information

Treatment and management of study participants will be based on the results of the local standard of laboratory tests performed at each hospital and assessment of the attending physician. Hospital test results, diagnosis and treatment data will be abstracted and collected.
The status of all patients tested for diarrhea (whatever the results from the laboratory test are) will be assessed through calling the patients or their caregivers, 60 days after the date of the stool sampling.


Management information

Registered date

2014 Year 10 Month 03 Day

Last modified on

2019 Year 10 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name