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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010771
Receipt No. R000012596
Scientific Title Search of causative agents of adult community-acquired pneumonia by the comprehensive real-time PCR
Date of disclosure of the study information 2013/05/31
Last modified on 2013/05/21

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Basic information
Public title Search of causative agents of adult community-acquired pneumonia by the comprehensive real-time PCR
Acronym Search of causative agents of adult community-acquired pneumonia by the comprehensive real-time PCR
Scientific Title Search of causative agents of adult community-acquired pneumonia by the comprehensive real-time PCR
Scientific Title:Acronym Search of causative agents of adult community-acquired pneumonia by the comprehensive real-time PCR
Region
Japan

Condition
Condition Ccommunity-acquired pneumonia in adult patients
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.For adult community-acquired pneumonia cases, we perform the comprehensive PCR for the detection of 12 kinds of
respiratory microbes (six kinds of bacteria, six kinds of viral ) by using nasopharyngeal swab and sputum specimen. We thereby determine a causative organisms of adult community-acquired pneumonia.
2.We also clarify the frequencies of drug resistance, microbiological diagnostic method, and the clinical features of clinical manifestations and image findings, the recommendation of antimicrobial agent and the duration of treatment about the M. pneumoniae infection
Basic objectives2 Others
Basic objectives -Others 1.To evaluate causative organisms of the adult community-acquired pneumonia
2.To clarify as below about Mycoplasma pneumoniae,
Microbiological diagnostic method
Clinical features such as clinical
manifestations and image findings
The frequency of drug-resistant,
recommendation of antimicrobial
agent, and the duration of treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.To evaluate causative organisms of the adult community-acquired pneumonia
2.To clarify as below about Mycoplasma pneumoniae,
Microbiological diagnostic method
Clinical features such as clinical
manifestations and image findings
The frequency of drug-resistant,
recommendation of antimicrobial
agent, and the duration of treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Community-acquired pneumonia cases among age 20 years old or older.
2.Within seven days from the onset.
3.Both of cases with and without previous history of taking antimicrobial agents enrolled
4.With Informed Concent.
Key exclusion criteria 1.Age under 20 years old
2.Occurred in 48 hours later after the
admission
3.More than 8 days after the onset
4.No agreement.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichiro Shimizu
Organization The Jikei University School of Medicine
Division name Respiratory medicine
Zip code
Address 3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8471
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Shimizu
Organization The Jikei University School of Medicine
Division name Respiratory medicine
Zip code
Address 3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8471
TEL
Homepage URL
Email

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization DAIICHI SANKYO Co., Ltd.
MEIJI SEIKA PHARMA CO.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato University, Kitasato Institute for life science.
Toranomon Hospital.
National Center for Global Health and Medicine,and other institutions
Name of secondary funder(s)

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 東京慈恵会医科大学(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 31 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
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 30 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.For adult community-acquired pneumonia cases, we perform the comprehensive PCR for the detection of 12 kinds of respiratory microbes (six kinds of bacteria, six kinds of viral *) by using nasopharyngeal swab and sputum specimen. We thereby determine a causative organisms of adult community-acquired pneumonia.
2.We also clarify the frequencies of drug resistance, microbiological diagnostic method, and the clinical features of clinical manifestations and image findings, the recommendation of antimicrobial agent and the duration of treatment about the M. pneumoniae infection

Management information
Registered date
2013 Year 05 Month 21 Day
Last modified on
2013 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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