UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of the utility of procalcitonin (PCT) in patients with pneumonia.
Title of the study (Brief title)	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	Tadashi Ishida
Organization	Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name	Dept. of Respiratoy Medicine
Address	1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Email	ishidat@kchnet.or.jp

Public contact
Name of contact person	Akihiro Ito
Organization	Ohara Memorial Healthcare Foundation Kurashiki Central Hospital
Division name	Dept. of Respiratoy Medicine
Address	1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	ai12306@kchnet.or.jp

Sponsor
Institute	Health Promoting Association for Respiratory Medicine of Nishi-Nippon
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013531