UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034507
Receipt number 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 16:35:51

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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 or person

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name



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

Value
https://center6.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