UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006863 |
|---|---|
| Receipt number | 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 23:02:10 |
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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
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
mycobacteriumtuberculosis@hotmail.com
Sponsor or person
Institute
Department of Respiratory Medicine
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008020
