UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011566 |
|---|---|
| Receipt number | R000013531 |
| Scientific Title | Prospective study of the utility of procalcitonin (PCT) in patients with pneumonia. |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2017/11/25 11:12:14 |
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Basic information
Public title
Prospective study of the utility of procalcitonin (PCT) in patients with pneumonia.
Acronym
Prospective study of PCT for pneumonia
Scientific Title
Prospective study of the utility of procalcitonin (PCT) in patients with pneumonia.
Scientific Title:Acronym
Prospective study of PCT for pneumonia
Region
| Japan |
Condition
Condition
community-acquired pneumonia (CAP)
nursing and healthcare-associated pneumonia (NHCAP)
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of PCT in the management of pneumonia
Basic objectives2
Others
Basic objectives -Others
To investigate whether consecutive measurements of PCT will predict the prognosis, severity, initial antimicrobial efficacy, and causative pathogens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Mortality in hospital
2)Initial antimicrobial efficacy
3)Severity of pneumonia
4)Causative pathogens
Key secondary outcomes
1)Comparison with the utility of CRP
2)Comparison with foreign reports
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
Community-acquired pneumonia (CAP) patients or nursing and healthcare-associated pneumonia (NHCAP) patients presenting with new infiltrative shadows on chest X-rays, and symptoms of acute respiratory infection, such as cough, sputum, fever, dyspnea, and chest pain.
Key exclusion criteria
Hospital acquired pneumonia
Active lung cancer
Suspected of pulmonary tuberculosis
Patients who do not agree with the enrollment to this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Ishida |
Organization
Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name
Dept. of Respiratoy Medicine
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
ishidat@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Ito |
Organization
Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name
Dept. of Respiratoy Medicine
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
Homepage URL
ai12306@kchnet.or.jp
Sponsor or person
Institute
Health Promoting Association for Respiratory Medicine of Nishi-Nippon
Institute
Department
Personal name
Funding Source
Organization
Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University Hospital
Shiga University of Medical Science Hospital
Mitsubishi Kyoto Hospital
Kyoto Katsura Hospital
Kitano Hospital
Osaka Red Cross Hospital
Osaka Saiseikai Nakatsu Hospital
Kobe City Medical Center General Hospital
Yoka Hospital
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
公益財団法人大原記念倉敷中央医療機構倉敷中央病院(岡山県)、京都大学医学部附属病院(京都府)、滋賀医科大学附属病院(滋賀県)、三菱京都病院(京都府)、京都桂病院(京都府)、北野病院(大阪府)、大阪赤十字病院(大阪府)、済生会中津病院(大阪府)、神戸市立中央市民病院(兵庫県)、公立八鹿病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is prospective observation study.
Patiens with pneumonia in attending hospitals are enrolled.
Management information
Registered date
| 2013 | Year | 08 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013531
