UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006437 |
|---|---|
| Receipt number | R000007641 |
| Scientific Title | Loopamp Mycoplasma P detection kit Evaluation Study |
| Date of disclosure of the study information | 2011/09/30 |
| Last modified on | 2014/01/06 17:24:23 |
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Basic information
Public title
Loopamp Mycoplasma P detection kit
Evaluation Study
Acronym
Myco-LAMP Evaluation Study
Scientific Title
Loopamp Mycoplasma P detection kit
Evaluation Study
Scientific Title:Acronym
Myco-LAMP Evaluation Study
Region
| Japan |
Condition
Condition
Community acquired pneumonia (CAP) meeting the criteria of atypical pneumonia
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Loopamp Mycoplasma P diagnosis kit (Myco-LAMP) for diagnosis performance in CAP
patients
Basic objectives2
Others
Basic objectives -Others
Evaluation of Myco-LAMP for
diagnosis performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate a clinical performance of Myco-LAMP for a pneumonia diagnosis in comparison of conventional IVDs and nucleic acid detection methodology.
1) Comparison of Myco-LAMP and serological test
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and serological test.
2) Comparison of Myco-LAMP and EIA (Immuno-Card)
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and EIA.
3) Comparison of Myco-LAMP and PCR
Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and PCR
Key secondary outcomes
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) Regardless of inpatient or
outpatient.
2) Suspected CAP patient who
presents a new typical infiltrative shadow on CXR or CT image taken <48 hr before this study and who shows at least one other typical symptom described below
Coughing, or its exacerbation
Purulent sputum or its deteriorating.
Abnormal finding based on auscultation and percussion
Breathing difficulties and/ or Tachypnea
Fever with > 37 degree (axilla measurement)
CRP increasing (in according to an criteria of each study site)
Hypoxemia
3) Case which meets the criteria of 1) & 2) and which is suspected as atypical pneumoniae based on the policies to distinguish between atypical and bacterial pneumonia (Japanese Respiratory Society guidelines of community acquired pneumonia 2007)
4) Eligible patient who provides the informed consent signed by himself or his proxy.
Key exclusion criteria
1) Patient for whom a clinical follow-up and a clear final diagnosis are judged to be difficult.
2) Patient who is obviously suspected to be TB, lung suppuration, pneumonia complicating with lung cancer or HIV.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Imamura |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
yimamura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Miyazaki |
Organization
Nagasaki evaluation organization for clinical interventions
Division name
office
Zip code
Address
Miyamura bld. 2F,11-13, Hirano-machi, Nagasaki city, Nagasaki prefecture.
TEL
095-842-5402
Homepage URL
shinkin@peath.co.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
Funding Source
Organization
Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Eiken Chemical Co., Ltd.
Name of secondary funder(s)
Eiken Chemical Co., Ltd.
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
| 2011 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007641
