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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003306
Receipt No. R000004001
Scientific Title Epidemiological study for hospitalized patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in Japan: a prospective multicenter follow-up study (CJLSG 0911)
Date of disclosure of the study information 2010/03/09
Last modified on 2013/10/22

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Basic information
Public title Epidemiological study for hospitalized patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in Japan: a prospective multicenter follow-up study (CJLSG 0911)
Acronym Epidemiological study for hospitalized patients with CAP, HCAP, HAP, and VAP in Japan (CJLSG 0911)
Scientific Title Epidemiological study for hospitalized patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in Japan: a prospective multicenter follow-up study (CJLSG 0911)
Scientific Title:Acronym Epidemiological study for hospitalized patients with CAP, HCAP, HAP, and VAP in Japan (CJLSG 0911)
Region
Japan

Condition
Condition community-acquired (CAP), health-care-associated (HCAP), hospital-acquired (HAP), and ventilator-associated pneumonia (VAP)
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 - To investigate clinical and microbiological features in patients with CAP, HCAP, HAP, and VAP, including backgrounds, outcomes, identified pathogens, antimicrobial susceptibilities, and risk factors for drug resistant pathogens
- To propose the appropriate initial assessment and empirical treatment for patients with CAP, HCAP, HAP, and VAP
Basic objectives2 Others
Basic objectives -Others Backgrounds, outcomes, identified pathogens and drug resistance, antimicrobial susceptibilities, Adherence to practice guidelines, etc.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) 30-day mortality and in-hospital mortality
2) Identified pathogens and drug resistance
3) Early and late treatment failure
4) Appropriateness of antibiotic treatment
5) Outcomes and their clinical prediction rules for patients with each category of pneumonia (CAP, HCAP, HAP, and VAP)
6) Adherence to practice guidelines in initial empirical antibiotic treatment for patients with each category of pneumonia (CAP, HCAP, HAP, and VAP)
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 The presence of a new infiltrate on a chest X-ray, or a computed tomography scan, plus at least 2 of the following criteria: 1) cough or purulent sputum, 2) pleuritic chest pain, 3) dyspnea, 4) fever or hypothermia (temperature >= 38 degrees or < 35 degrees), 5) white blood cell count >= 10,000 /mm3 or < 4,000 /mm3, and 6) hypoxemia (SpO2 < 90% or PaO2 < 60 Torr) or decline in oxygenation
Key exclusion criteria 1) Patients who do not receive initial empirical antibiotic treatment
2) Patients with obstructive pneumonia
3) Pneumonia occurred in other hospitals and patients who were transferred from their hospitals with a tendency to improve
4) Patients whose pneumonia recurred within 3 days after the last day of antibiotic treatment of a preceding pneumonia episode
5) Patients who receive the treatment in an outpatient clinic
6) Patients who are less than 20 years old
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Hasegawa
Organization Nagoya University Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2167
Email yhasega@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Shindo
Organization Nagoya University Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2167
Homepage URL
Email yshindo@med.nagoya-u.ac.jp

Sponsor
Institute Central Japan Lung Study Group
Institute
Department

Funding Source
Organization Central Japan Lung Study Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 名古屋大学医学部附属病院(愛知県)
JA愛知厚生連豊田厚生病院(愛知県)
トヨタ記念病院(愛知県)
大垣市民病院(岐阜県)
公立陶生病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋掖済会病院(愛知県)
豊橋市民病院(愛知県)
名古屋第一赤十字病院(愛知県)
名古屋第二赤十字病院(愛知県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23855620
Number of participants that the trial has enrolled
Results
http://www.ncbi.nlm.nih.gov/pubmed/23855620
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
2009 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information - This study is a prospective observational study.
- In Nagoya University Hospital and Toyota Kosei Hospital, patients with CAP, HCAP, HAP, and VAP are enrolled in this study; in other institutions, those with HAP and VAP are not enrolled.

Management information
Registered date
2010 Year 03 Month 09 Day
Last modified on
2013 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004001

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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