UMIN-CTR Clinical Trial

Basic information
Public title	A study of the new Legionella pneumophila urinary antigen kit study number:LAC-116-01-KC
Acronym	A study of Legionella pneumophila urinary antigen
Scientific Title	A study of the new Legionella pneumophila urinary antigen kit study number:LAC-116-01-KC
Scientific Title:Acronym	A study of Legionella pneumophila urinary antigen
Region	Japan

Condition
Condition	pneumonia
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the usefulness of a new rapid urinary antigen kit for diagnosis of Legionella pneumonia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic performance for Legionella pneumonia
Key secondary outcomes	Analysis of concordance rate between a new rapid urinary antigen kit and other kits

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who show acute respiratory symptoms and are suspected to have Legionella pneumonia 2.A urine sample is available 3.Patients who have provided informed consent signed by either themselves or their proxy
Key exclusion criteria	Patients for whom clinical follow-up and a clear final diagnosis are judged to be difficult
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akihiro Ito
Organization	Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Email	ai12306@kchnet.or.jp

Public contact
Name of contact person	1st name Middle name Last name Akihiro Ito
Organization	Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	ai12306@kchnet.or.jp

Sponsor
Institute	Ohara Memorial Healthcare Foundation Kurashiki Central Hospital Dept. of Respiratory Medicine
Institute
Department

Funding Source
Organization	Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	東邦大学医学部微生物・感染症学講座(東京都) 東邦大学医療センター大森病院(東京都) 公益財団法人大原記念倉敷中央医療機構　倉敷中央病院(岡山県) 公益財団法人　天理よろづ相談所病院(奈良県) 国家公務員共済組合連合会　虎の門病院(東京都) 社会福祉法人　恩賜財団済生会　山形済生病院(山形県) 国家公務員共済組合連合会　三宿病院(東京都) 東京慈恵会医科大学附属　第三病院(東京都) 独立行政法人地域医療機能推進機構　東京山手メディカルセンター(東京都) 東京都立　多摩総合医療センター(東京都) 千葉市立青葉病院(千葉県) 関西医科大学附属枚方病院(大阪府) 独立行政法人国立病院機構　沖縄病院(沖縄県) 社会医療法人　敬愛会　中頭病院(沖縄県) 富山大学附属病院(富山県) 富山市立　富山市民病院(富山県) 富山県厚生農業協同組合連合会　高岡病院(富山県) 黒部市民病院(富山県)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 16 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	Completed
Date of protocol fixation	2016 Year 04 Month 19 Day
Date of IRB	2016 Year 04 Month 06 Day
Anticipated trial start date	2016 Year 05 Month 16 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 06 Month 27 Day
Date trial data considered complete	2019 Year 06 Month 30 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	This study is a prospective observation study. Subjects: All patients diagnosed with pneumonia and meet the selection criteria between 16 May 2016 to 31 December 2018 in participating institutions. Examination items: Vital signs, blood examinations, sputum examinations, urinalysis and chest X-ray photo.

Management information
Registered date	2016 Year 05 Month 13 Day
Last modified on	2020 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025692