UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001118
Receipt number R000001352
Scientific Title A prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.
Date of disclosure of the study information 2008/04/09
Last modified on 2008/12/02 22:23:29

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Basic information

Public title

A prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.

Acronym

HIRA-TAN cutoff study.

Scientific Title

A prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.

Scientific Title:Acronym

HIRA-TAN cutoff study.

Region

Japan


Condition

Condition

Pneumonia(acute)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the validity of the cutoff values used in HIRA-TAN.

Basic objectives2

Others

Basic objectives -Others

The validity of the cutoff values.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Validity of the cutoff value for P. pneumoniae.

Key secondary outcomes

Validity of the cutoff values for H. influenzae, P. aeruginosa, and M. catarrhalis.
Overall performance of HIRA-TAN system to identify the causative pathogen.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who fulfill the criteria 1-3 and provided sputum that fulfill the criteria 4.
1. Patients who have newly developed infiltrations in the chest imaging study and have clinical symptoms that support pneumonia.
2. Bacterial culture of the sputum is submitted.
3. Urine antigen test for P. pneumoniae is submitted.
4. Sputum that is isolated within 48 hours of the development of symptoms of pneumonia and is classified into Miller-Hones M2, P1, P2, or P3 is provided.

Key exclusion criteria

Patients that do not fulfill the inclusion criteria.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Hagiwara

Organization

Saitama Medical University

Division name

Department of Respiratory Medicine

Zip code


Address

38 Morohongo Moroyama Saitama 350-0495 Japan

TEL

049-276-1319

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Hirama

Organization

Saitama Medical University

Division name

Department of Respiratory Medicine

Zip code


Address

38 Morohongo Moroyama Saitama 350-0495 Japan

TEL

049-276-1319

Homepage URL


Email

mycobacteriumtuberculosis@hotmail.com


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2008 Year 04 Month 09 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

2008 Year 04 Month 08 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2008 Year 10 Month 01 Day

Date of closure to data entry

2008 Year 10 Month 01 Day

Date trial data considered complete

2008 Year 10 Month 01 Day

Date analysis concluded

2008 Year 10 Month 01 Day


Other

Other related information

Identify the pathogen present in the sputum using HIRA-TAN. Investigate the percentage of the pneumonia where S. pneumoniae is diagnosed as a significant pathogen by HIRA-TAN out of pneumonia where S. pneumoniae is diagnosed as the definitely causative pathogen using the existing laboratory or bacteriological tests.


Management information

Registered date

2008 Year 04 Month 09 Day

Last modified on

2008 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001352


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name