UMIN-CTR Clinical Trial

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

Pneumonia

Classification by specialty

Medicine in general	Pneumology	Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Pfizer

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Chikamori Hospital, Kochi
Kameda Medical Center, Chiba
Ebetsu Municipal Hospital, Hokkaido
Jyuzenkai Hospital, Nagasaki

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Published

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

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 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).

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