UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006104 |
|---|---|
| Receipt number | R000007224 |
| Scientific Title | Evaluation of a rapid immunochromatographic assay (Rapirun Streptococcus pneumoniae) for detecting Streptococcus pneumoniae antigen in sputum |
| Date of disclosure of the study information | 2011/08/03 |
| Last modified on | 2023/02/09 14:54:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of a rapid immunochromatographic assay (Rapirun Streptococcus pneumoniae) for detecting Streptococcus pneumoniae antigen in sputum
Acronym
Detecting S. pneumoniae antigen in sputum
Scientific Title
Evaluation of a rapid immunochromatographic assay (Rapirun Streptococcus pneumoniae) for detecting Streptococcus pneumoniae antigen in sputum
Scientific Title:Acronym
Detecting S. pneumoniae antigen in sputum
Region
| Japan |
Condition
Condition
lower respiratory tract infection
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to prove the usefulness of immunochromatographic rapid method (Rapirun Streptococcus pnemoniae) for detecting Streptococcus pneumoniae antigen and to its performance in clinical settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the immunochromatographic rapid method (Rapirun Streptococcus pnemoniae) and result of culture for detecting Streptococcus pneumoniae in adult lower respiratory tract infection cases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Laboratory examinations below will be performed before the treatment of lower respiratory tract infection cases
1) Rapirun Streptococcus pneumponiae using sputum
2) culture of sputum
3) quantitative culture of sputum
4) Gram stain of sputum
5) urinary Streptococcus pneumoniae antigen test
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
adult patients with lower respiratory tract infection who meets the factors below
1) age
2) Gender
3)inpatient and outpatient
4)ability to acquire sputum and urine
5)no prior antimicrobial treatment (2 weeks)
Key exclusion criteria
1) patients who undergoes macrolides maintenance treatment
2) patients who were considered as not appropriate to register to study by attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Izumikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7731
koizumik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Izumikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Molecular Microbiology and Immunology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7273
Homepage URL
koizumik@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
Tel
095-819-7731
koizumik@nagasaki-u.ac.jp
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
| 2011 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
n.a.
Publication of results
Published
Result
URL related to results and publications
ACTA MEDICA NAGASAKIENSIA in press
Number of participants that the trial has enrolled
192
Results
Conclusion: In adult patients with respiratory tract infections in whom sputum collection is feasible, RAPIRUN will increase the diagnostic efficacy of S. pneumoniae infection.
Results date posted
| 2023 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Results: A total of 192 patients were analyzed. Of these, 167 were diagnosed with pneumonia (87.0%) including 161 of community-acquired pneumonia. Of the 192 cases, 86 (44.8%) were culture-proven for S. pneumoniae.
Participant flow
n.a.
Adverse events
n.a.
Outcome measures
The correlation between the positivity rate and the amount of S. pneumoniae in sputum by quantitative culture tests. This prospective study compared the performance of RAPIRUN and BinaxNow in approximately 200 adult patients with lower respiratory tract infections in clinical settings after the launch of RAPIRUN in 2010. One of the most distinguished highlights from previous reports is the real-world analysis of the detectable amount of S. pneumoniae by RAPIRUN using quantitative sputum culture.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007224
