UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022298
Receipt number R000025692
Scientific Title A study of the new Legionella pneumophila urinary antigen kit study number:LAC-116-01-KC
Date of disclosure of the study information 2016/05/16
Last modified on 2020/05/20 15:44:55

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name