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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006863
Receipt No. R000008020
Scientific Title A clinical study that investigates the ability of the HIRA-TAN to shorten the time required for the transition from an empiric therapy to a specific therapy in adult pneumonia.
Date of disclosure of the study information 2011/12/08
Last modified on 2015/06/09

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Basic information
Public title A clinical study that investigates the ability of the HIRA-TAN to shorten the time required for the transition from an empiric therapy to a specific therapy in adult pneumonia.
Acronym Early initiation of specific therapy with HIRA-TAN
Scientific Title A clinical study that investigates the ability of the HIRA-TAN to shorten the time required for the transition from an empiric therapy to a specific therapy in adult pneumonia.
Scientific Title:Acronym Early initiation of specific therapy with HIRA-TAN
Region
Japan

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

Objectives
Narrative objectives1 Investigation on the ability of the HIRA-TAN to shorten the time required for the transition from an empiric therapy to a specific therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigation on the ability of the HIRA-TAN to shorten the time required for the transition from an empiric therapy to a specific therapy.
Key secondary outcomes Comparison of the overall performance of HIRA-TAN system and conventional method to identify the causative pathogen of pneumonia.
Comparison of the cost between HIRA-TAN system and conventional method required for identification of the casative pathogen of pneumonia.
Validity of the cutoff values that identify pathogenic roles of the commensal organisms in pneumonia; the organisms include S. pneumoniae, H. influenzae, M.catarrhalis, P. aeruginosa, A. baumannii, S. maltophilia, S. aureus, E. coli and S.marcescens.

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 All inpatient and outpatient with pneumonia (aged 18 and older) who fulfill the criteria 1-4 and provid sputum classified as Miller and Jones M2, P1, P2 or P3.

1. Gram stain and culture of expectorated sputum is submitted before the treatment.
2. Urine antigen test for S. pneumoniae is submitted.
3. Blood sample for bacterial culture and Urine antigen test for L. pneumophila are submitted(cases that admit to the hospital only).
4. Influenza antigen test is submitted(flu season only).
Key exclusion criteria Patients that do not fulfill the inclusion criteria.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Hirama
Organization Saitama Medical University
Division name Respiratory Medicine
Zip code
Address 38 Morohongo Moroyama Saitama 350-0495 Japan
TEL +81-49-276-1319
Email mycobacteriumtuberculosis@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Hirama
Organization Saitama Medical University
Division name Respiratory medicine
Zip code
Address 38 Morohongo Moroyama Saitama 350-0495 Japan
TEL +81-49-276-1319
Homepage URL http://hira-tan.com
Email mycobacteriumtuberculosis@hotmail.com

Sponsor
Institute Department of Respiratory Medicine
Saitama Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science(JSPS), Grant-in-Aid for Young Scientists(B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Adaptable and Seamless Technology Transfer Program through Target-driven R&D from Japan Science and Technology Agency

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 埼玉医科大学病院(埼玉県),埼玉医科大学国際医療センター(埼玉県),関越病院(埼玉県),池の台病院(埼玉県),毛呂病院(埼玉県),ミオ医院(神奈川県),武蔵台病院(埼玉県),入間台クリニック(埼玉県),大野クリニック(埼玉県),気仙沼市立病院(宮城県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 08 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
2011 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2015 Year 06 Month 09 Day
Date of closure to data entry
2015 Year 06 Month 09 Day
Date trial data considered complete
2015 Year 06 Month 09 Day
Date analysis concluded
2015 Year 06 Month 09 Day

Other
Other related information We developed a new PCR-based diagnostic test for the pneumonia. We call it HIRA-TAN; it's abbreviation: Human cell controlled Identification of Respiratory Agent from TAN, which stands for sputum in Japanese.

The most prominent feature of the HIRA-TAN is its ability to differentiate therapeutic target and non-therapeutic target for commensal organism (The Japanese Patent (Patent No.4665203) obtained and PCT/JP2009/053976 pending).

HIRA-TAN combines the PCR system using cutoff value to discriminate the therapeutic target for commensal organism with the PCR system for non-commensal organism where the detected organism is concluded to be a causative pathogen (Hirama T, et al. PLoS One. 2011; 6(9): e24474).

That's why HIRA-TAN is a PCR-based comprehensive test by sputum and sensitive and rapid one, requiring within 4 h to complete.

Management information
Registered date
2011 Year 12 Month 08 Day
Last modified on
2015 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008020

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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