UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical characteristics, outcome and distribution of Nocardiosis in Japan
Title of the study (Brief title)	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	Hotoshi Honda
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Infectious diseases
Address	2-8-29, Musashidai, Fuchu-city, Tokyo, Japan
TEL	042-323-5111
Email	tama.idconsult@gmail.com

Public contact
Name of contact person	Yasuaki Tagashira
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Infectious diseases
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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