UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017787 |
|---|---|
| Receipt number | R000020575 |
| Scientific Title | Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/12/03 09:46:54 |
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Basic information
Public title
Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Acronym
Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Scientific Title
Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Scientific Title:Acronym
Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Region
| Japan |
Condition
Condition
Mycoplasma peumoniae infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Mycoplasma pneumoniae detection kit for the diagnosis performance using a pharynx wiping liquid obtained from patients with respiratory infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between Mycoplasma pneumoniae antigen detection kit and quantitative polymerase chain reaction (q-PCR).
Key secondary outcomes
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between the following conventional test and q-PCR.
LAMP
Serological test
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A patient over 15 years old with respiratory infection symptom.
2) A patient or legally authorized representative must provide written informed consent.
Key exclusion criteria
1) Specimens are not obtained from a patient.
2) A patient who had been enrolled this study.
3) An investigator determines that a patient is unsuitable for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Izumikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Unit of Molecular Microbiology and Immunology Department of Infectious Disease
Zip code
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 | |
| Middle name | |
| Last name | Koichi Izumikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Unit of Molecular Microbiology and Immunology Department of Infectious Disease
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7731
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
Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2015 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 15 | 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
| 2015 | Year | 06 | Month | 03 | Day |
Last modified on
| 2015 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020575
