UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001694 |
|---|---|
| Receipt number | R000002042 |
| Scientific Title | A multicenter 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 | 2009/02/06 |
| Last modified on | 2010/10/14 16:06:57 |
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Basic information
Public title
A multicenter prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.
Acronym
HINF study
Scientific Title
A multicenter prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.
Scientific Title:Acronym
HINF study
Region
| Japan |
Condition
Condition
Pneumonia (acute lower respiratory infection)
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To 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 Haemophilus influenzae and Pseudomonas spp..
Key secondary outcomes
Validity of the cutoff values for Moraxella catarrhalis, Klebsiella pneumoniae, and Stahylococcus aureus.
Overall performance of HIRA-TAN system to identify the causative pathogen of pneumonia.
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 S. 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
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Hirama |
Organization
Saitama Medical University
Division name
Re
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
Respiratory medicine
Zip code
Address
38 Morohongo Moroyama Saitama 350-0495 Japan
TEL
Homepage URL
mycobacteriumtuberculosis@hotmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
(1) Japan Society for the Promotion of Science(JSPS), Grant-in-Aid for Young Scientists (B)
(2) An alumni association of Saitama medical University, Grant from Ochiai memorial award 2009
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
(3) Saitama Medical University Internal Grant 09-01
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 Saitama Medical University Hospiratl, 埼玉医科大学国際医療センター Saitama Medical University International Medical Center, 関越病院 Kan-etsu Hospital, 埼玉社会保険病院 Saitama Social Insurance Hospital, 鶴ヶ島池の台病院 Tsurugashima Ikenodai Hospital, 大野クリニック Ohno clinic, 気仙沼市立病院 Kesennuma City Hospital,
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 06 | 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
The primary endpoint for the last study (UMIN ID: UMIN000001118) was the proportion of the samples in which S. pneumoniae was judged as a significant pathogen on HIRA-TAN compared to that in which S. pneumoniae was shown to be a causative pathogen on existing test. The proportion was 0.93 (40/43; 95% confidence interval (CI): 0.83<), as a Sensitivity, and a Negative Predictive Value was also 0.93.
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
| 2009 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Identify the pathogen present in the sputum using HIRA-TAN. Investigate the percentage of the pneumonia where H. influenzae or Pseudomonas spp. are diagnosed as a significant pathogen by HIRA-TAN out of pneumonia where H. influenzae or Pseudomonas spp. are diagnosed as the definitely causative pathogen using the existing laboratory or bacteriological tests.
Management information
Registered date
| 2009 | Year | 02 | Month | 06 | Day |
Last modified on
| 2010 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
