UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007090 |
|---|---|
| Receipt number | R000008350 |
| Scientific Title | A prospective observational study for patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in a Japanese University Hospital |
| Date of disclosure of the study information | 2012/01/17 |
| Last modified on | 2012/01/17 19:16:08 |
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Basic information
Public title
A prospective observational study for patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in a Japanese University Hospital
Acronym
A prospective observational study for hospitalized patients with CAP, HCAP, HAP, and VAP in a Japanese University Hospital
Scientific Title
A prospective observational study for patients with community-acquired, health-care-associated, hospital-acquired, and ventilator-associated pneumonia in a Japanese University Hospital
Scientific Title:Acronym
A prospective observational study for hospitalized patients with CAP, HCAP, HAP, and VAP in a Japanese University Hospital
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 their drug resistance, antimicrobial susceptibilities, and molecular genetic characteristics, adherence to practice guidelines, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
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)
7) molecular genetic characteristics of identified pathogens
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
1420
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
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
yshindo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
- This study is a prospective observational study.
- In this study, patients who were enrolled in the previous study, "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; UMIN000003306)," are included. And, patients who were prospectively listed in the institutional pneumonia database after the end of enrollment of the CJSLG 0911 study are also included.
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2012 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008350
