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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001118
Receipt No. 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

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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
Institute Saitama Medical University
Institute
Department

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
URL(English) https://upload.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


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