UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006909
Receipt number R000008166
Scientific Title Prospective Surveillance for Community-Acquired Pneumonia and Healthcare-Associated Pneumonia among Japanese Adults: Multicenter Study
Date of disclosure of the study information 2011/12/31
Last modified on 2016/08/22 16:12:09

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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 or person

Institute

Nagasaki University

Institute

Department

Personal name



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

Value
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