UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000030535
Receipt No. R000034861
Scientific Title Clinical epidemiology of Carbapenem-resistant Enterobacteriaceae
Date of disclosure of the study information 2018/01/01
Last modified on 2019/12/24 (Ver. 6)

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Basic information
Public title Clinical epidemiology of Carbapenem-resistant Enterobacteriaceae
Acronym Clinical epidemiology of Carbapenem-resistant Enterobacteriaceae
Scientific Title Clinical epidemiology of Carbapenem-resistant Enterobacteriaceae
Scientific Title:Acronym Clinical epidemiology of Carbapenem-resistant Enterobacteriaceae
Region
Japan

Condition
Condition Patients with isolation of CRE
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinico-epidemiology & clinical impact, appropriate treatment, microbiological characteristics and its relation to clinical characteritics
Basic objectives2 Others
Basic objectives -Others clinical & microbiological evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical impact (mortality, length of hospital stay)
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 Patients with isolation of CRE or CPE who agree with participation to the study
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name HAYAKAWA
Organization National Center for Global Health and Medicine
Division name Disease Control and Prevention Center
Zip code 1628655
Address 1-21-1 Toyama, Shinjuku-ku Tokyo, 162-8655, Japan
TEL 03-3202-7181
Email khayakawa@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name HAYAKAWA
Organization National Center for Global Health and Medicine
Division name Disease Control and Prevention Center
Zip code 1628655
Address 1-21-1 Toyama, Shinjuku-ku Tokyo, 162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email khayakawa@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization JSPS KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization NCGM IRB
Address 1-21-1 Toyama Shinjuku Tokyo Japan
Tel 03-3202-7181
Email rinri@hosp.ncgm.go.jp

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
2018 Year 01 Month 01 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31789374
Publication of results Published

Result
URL related to results and publications https://idsa.confex.com/idsa/2018/webprogram/Paper70962.html
Number of participants that the trial has enrolled 88
Results 
Antibiotic resistance was more frequent in the CPE group than in the non-CPE group. Independent predictors for CPE isolation were identified. Although in-hospital and 30day mortality rates were similar between the two groups, LOS after CRE isolation was longer in the CPE group.
Results date posted
2019 Year 12 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
see manuscript
Participant flow 
Patients with isolations of CRE (MICs of meropenem >=2mg/L, imipenem >=2mg/L or cefmetazole >=64mg/L) from August 2016 to March 2018 were included
Adverse events 
NA
Outcome measures 
see manuscript
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
2016 Year 09 Month 27 Day
Anticipated trial start date
2016 Year 09 Month 28 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Parameters>
Background information, comorbidities, susceptibilities, antimicrobial exposures, isolation site, clinical symptoms & severity, outcomes

Management information
Registered date
2017 Year 12 Month 23 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034861