UMIN-CTR Clinical Trial

Basic information
Public title	The study on hospital surveillance of Clostridium difficile infection
Acronym	CDI surveillance
Scientific Title	The study on hospital surveillance of Clostridium difficile infection
Scientific Title:Acronym	CDI surveillance
Region	Japan

Condition
Condition	Clostridium difficile infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the incidence of Clostridium difficile infection(over 2 years old) in inpatient clinic
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The prevalence of Clostridium difficile infection
Key secondary outcomes	The risk factor of Clostridium difficile infection

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	2 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diarrhoea CD toxin positive in stool
Key exclusion criteria	Normal stool
Target sample size

Research contact person
Name of lead principal investigator	1st name Middle name Last name Soichi Arakawa
Organization	Kobe University Graduate School of Medicine
Division name	Department of Social/Community Medical and Health Science
Zip code
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5531
Email	soichi@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Yoshida
Organization	Kobe University Hospital
Division name	Department of Infection Control and Prevention
Zip code
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5531
Homepage URL
Email	hyoshida@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2013 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observational study Molecular epidemiology study of Clostridium difficile infections in university hospitals:Results of a nationwide study in Japan:Tokimatsu I, Shigemura K, Osawa K, Kinugawa S, Kitagawa K, Nakanishi N, Yoshida H, Arakawa S, Fujisawa M on behalf of the Research Group of Japan Infection Prevention and Control Conference for National and Public University Hospitals J Infect Chemother 24(8):641-647 2018

Management information
Registered date	2013 Year 11 Month 20 Day
Last modified on	2019 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014457