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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name