UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study
Acronym	Surveillance for Adult CAP and HCAP in Japan
Scientific Title	Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study
Scientific Title:Acronym	Surveillance for Adult CAP and HCAP in Japan
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary objectives: 1)To estimate the incidence of CAP and HCAP among Japanese population. 2)To determine the etiology of adult pneumonia and the serotype distribution of Streptococcus pneumoniae isolates. Secondary objectives: 1) To establish new laboratory techniques to identify pathogenic organisms from pneumonia patients. 2) To estimate the effectiveness of PPV against CAP among senior population. 3) To provide the baseline data for future PCV hard immunity study.
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) The incidence of CAP and HCAP among Japanese population 2) The etiology of adult pneumonia 3) The serotype distribution of Streptococcus pneumoniae isolates
Key secondary outcomes	1) New laboratory techniques to identify pathogenic organisms from pneumonia patients 2) The effectiveness of PPV against CAP among senior population 3) The baseline data for future PCV hard immunity study

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	Inclusion criteria All patients: 1) aged 15 years and over, 2) present to study hospitals with any clinical signs compatible with pneumonia, and 3) have consolidation on chest X-ray.
Key exclusion criteria	Exclusion criteria Hospital-acquired pneumonia (pneumonia developed after 48 hours of admission) Ventilator-associated pneumonia (pneumonia developed under intubation or mechanical ventilation)
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Konosuke Morimoto
Organization	Nagasaki University Institute of Tropical Medicine
Division name	Department of Clinical Medicine
Zip code
Address	1-12-4,Sakamoto,Nagasakishi,Nagasakiken
TEL	095-819-7842
Email	komorimo@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Konosuke Morimoto
Organization	Nagasaki University Institute of Tropical Medicine
Division name	Department of Clinical Medicine
Zip code
Address	1-12-4,Sakamoto,Nagasakishi,Nagasakiken
TEL	095-819-7842
Homepage URL
Email	komorimo@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Pfizer
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chikamori Hospital, Kochi Kameda Medical Center, Chiba Ebetsu Municipal Hospital, Hokkaido Jyuzenkai Hospital, Nagasaki
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	医療法人近森会近森病院（高知県） 医療法人鉄蕉会亀田総合病院（千葉県） 江別市立病院（北海道） 社会福祉法人　十善会病院(長崎）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/25822890
Number of participants that the trial has enrolled
Results	A total of 1,772 COP episodes out of 932,080 hospital visits were enrolled during the surveillance. The estimated overall incidence rates of adult COP, hospitalization, and in-hospital death were 16.9 (95% confidence interval, 13.6 to 20.9), 5.3 (4.5 to 6.2), and 0.7 (0.6 to 0.8) per 1,000 person-years (PY), respectively. The incidence rates sharply increased with age.
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	Main results already published
Date of protocol fixation	2011 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded

Other

Other related information

The estimated annual number of adult COP cases in the entire Japanese population was 1,880,000. Aspiration-associated pneumonia (630,000) was the leading etiologic category, followed by Streptococcus pneumoniae-associated pneumonia (530,000), Haemophilus influenzae-associated pneumonia (420,000), and respiratory virus-associated pneumonia (420,000), including influenza-associated pneumonia (30,000).

Management information
Registered date	2011 Year 12 Month 19 Day
Last modified on	2016 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008166

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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