UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000015336 |
| Receipt No. | 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 (Ver. 7) |
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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 |
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| Condition | ||
| Condition | Clostridium difficile infection (CDI) | |
| Classification by specialty |
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| 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 | |
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| Randomization | |
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| Blinding | |
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| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 | |||
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| Name of lead principal investigator |
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| 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 | ||||||
| cato@nih.go.jp | |||||||
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| Name of contact person |
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| 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 | |||||||
| cato@nih.go.jp | |||||||
| Sponsor | |
| Institute | National Institute of Infectious Diseases |
| Institute | |
| Department | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| 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). |
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| 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. |
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| Adverse events | Not applicable |
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| Outcome measures | Not applicable |
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| Recruitment status | Completed | ||||||
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| 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. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017822 |
