UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012326 |
|---|---|
| Receipt number | R000014410 |
| Scientific Title | Evaluation of a rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum |
| Date of disclosure of the study information | 2013/11/18 |
| Last modified on | 2013/11/18 12:06:57 |
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Basic information
Public title
Evaluation of a rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum
Acronym
Evaluation of a rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum
Scientific Title
Evaluation of a rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum
Scientific Title:Acronym
Evaluation of a rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum
Region
| Japan |
Condition
Condition
Patients with Streptococcus pneumonia who has positive urine S.pneumonia antigen test
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of rapid immunochromatographic assay for detecting Streptococcus pneumoniae antigen in sputum in diagnosis and treatment of patients with S. penumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between this kit and culture of sputum
Key secondary outcomes
Comparison between this kit and urine S.pneumonia antigen test
Comparison between this kit and investigation of causative bacteria by Gram staining
Comparison between this kit and clinical efficacy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pneumonia according to the Japan Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults.
Key exclusion criteria
1.Patients who had been treated with antibiotics within 2 weeks
2.Patients deemed ineligible by the attending physicians for various reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Kawanami |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
namihei@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Noguchi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
093-603-1611
Homepage URL
sn0920@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine,University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine,University of Occupational and Environmental Health, Japan
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
| 2013 | Year | 11 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective study.
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014410
