UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006198 |
|---|---|
| Receipt number | R000007329 |
| Scientific Title | Survey of the Actual Situation of Diagnosis/Treatment of MRSA Pneumonia |
| Date of disclosure of the study information | 2011/08/20 |
| Last modified on | 2014/08/19 17:38:00 |
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Basic information
Public title
Survey of the Actual Situation of Diagnosis/Treatment of MRSA Pneumonia
Acronym
Survey of the Actual Situation of Diagnosis/Treatment of MRSA Pneumonia
Scientific Title
Survey of the Actual Situation of Diagnosis/Treatment of MRSA Pneumonia
Scientific Title:Acronym
Survey of the Actual Situation of Diagnosis/Treatment of MRSA Pneumonia
Region
| Japan |
Condition
Condition
MRSA pneumonia (including suspected cases)
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In cases of pneumonia where anti-MRSA drugs were used, the following will be evaluated in the actual use situation.
1)For cases of hospital-acquired pneumonia diagnosed In accordance with the "JRS Guidelines for the Management of Hospital-Acquired Pneumonia in Adults" (The Japanese Respiratory Society, revised in June 2008), the reason for diagnosing MRSA pneumonia, the frequency of isolating MRSA, the appropriateness of the anti-MRSA drug used, etc. will be evaluated.
2) Also for cases of community-acquired pneumonia and health care-related pneumonia, the reason for diagnosing MRSA pneumonia, the frequency of isolating MRSA, the appropriateness of the anti-MRSA drug used, etc. will be evaluated if an anti-MRSA drug is used.
Basic objectives2
Others
Basic objectives -Others
Reveal the actual situation of diagnosis and treatment of MRSA pneumonia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Reveal the actual situation of diagnosis and treatment of MRSA pneumonia.
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
Patients with MRSA pneumonia (including suspected cases) treated with an anti-MRSA drug
Key exclusion criteria
N/A
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
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
taiga-m@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
2-23-16, Kaminakano, Kita-ku, Okayama city, Okayama prefecture.
TEL
086-241-5311
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
Other
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 20 | 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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2011 | Year | 08 | Month | 19 | Day |
Last modified on
| 2014 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007329
