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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001694
Receipt No. 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

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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
Email

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
Email mycobacteriumtuberculosis@hotmail.com

Sponsor
Institute Saitama Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002042

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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