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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034507
Receipt No. R000039344
Scientific Title Clinical characteristics, outcome and distribution of Nocardiosis in Japan
Date of disclosure of the study information 2018/10/20
Last modified on 2018/10/15

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Basic information
Public title Clinical characteristics, outcome and distribution of Nocardiosis in Japan
Acronym Clinical study about Nocardisosis in Japan
Scientific Title Clinical characteristics, outcome and distribution of Nocardiosis in Japan
Scientific Title:Acronym Clinical study about Nocardisosis in Japan
Region
Japan

Condition
Condition Nocardiosis
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.To describe clinical characteristics, management and outcome in patients with nocardiosis diagnosed at Japanese institutions.
2.To describe the susceptibility to antimicrobial agents of Nocardia spp. in Japan
Basic objectives2 Others
Basic objectives -Others Clinical epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mortality
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
18 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria 1 Patients with age of above 18
2 Nocardia species isolated in clinical samples
3 Presence of signs and/or symptoms compatible with nocardiosis
4 Diagnosis made between January 2010 and December 2017
5 The clinical samples were sent and analyzed at Medical Mycology Research Center, Chiba University in Chiba, Japan.
Key exclusion criteria Imported cases from outside of Japan
Pediatric patients
Patients without consent from treating physicians
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hotoshi Honda
Organization Tokyo Metropolitan Tama Medical Center
Division name Infectious diseases
Zip code
Address 2-8-29, Musashidai, Fuchu-city, Tokyo, Japan
TEL 042-323-5111
Email tama.idconsult@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Tagashira
Organization Tokyo Metropolitan Tama Medical Center
Division name Infectious diseases
Zip code
Address 2-8-29, Musashidai, Fuchu-city, Tokyo, Japan
TEL 042-323-5111
Homepage URL
Email tama.idconsult@gmail.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Mycology Research Center (MMRC), Chiba University
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
2018 Year 10 Month 20 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will obtain demographic characteristics, clinical data, diagnosis, treatment data from electronic medical record. For microbiology data, we will obtain the name of subspecies of Nocardia, antimicrobial susceptibilities, and other important microbiology data from MMRC.

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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