UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030535 |
|---|---|
| Receipt number | 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 15:01:48 |
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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
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
khayakawa@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
