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
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
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
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
