UMIN-CTR Clinical Trial

Public title

Epidemiology Study on Incidence Rate of Pneumococcal Pneumonia and Distribution of Streptococcus Pneumoniae Serotypes in Residents aged 18 Years or Older in Goto City in Japan.

Acronym

Epidemiology Study on Incidence Rate of Pneumococcal Pneumonia and Distribution of Streptococcus Pneumoniae Serotypes in Residents aged 18 Years or Older in Goto City in Japan.

Scientific Title

Epidemiology Study on Incidence Rate of Pneumococcal Pneumonia and Distribution of Streptococcus Pneumoniae Serotypes in Residents aged 18 Years or Older in Goto City in Japan.

Scientific Title:Acronym

Epidemiology Study on Incidence Rate of Pneumococcal Pneumonia and Distribution of Streptococcus Pneumoniae Serotypes in Residents aged 18 Years or Older in Goto City in Japan.

Region

Japan

Condition

Community Acquired Pneumonia(CAP)

Classification by specialty

Medicine in general	Pneumology	Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Estimate the proportion of PCV13-serotype S. pneumoniae among adults 18 years of age and older in Goto Island presenting with radiographically-confirmed CAP.

Basic objectives2

Others

Basic objectives -Others

1) Describe the full distribution of all S. pneumoniae serotypes.
2) Estimate the incidence rate of CAP and S. pneumoniae positive radiographically-confirmed CAP (SP+ CAP).
3) Describe antibiotic resistance rates among S. pneumoniae isolates.
4) Describe the differences in detection of S. pneumoniae by culture, BinaxNOW®, and UAD assay.
5) Estimate the incidence rate of Community Onset Pneumonia (COP) and S. pneumoniae positive COP. COP includes Community Acquired Pneumonia (CAP) and Health Care Associated Pneumonia (HCAP).

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The overall proportion of subjects with clinically and radiographically - confirmed CAP who have any pneumococcal serotype in PCV13 detected by either UAD assay and/or culture.

Key secondary outcomes

1) The serotype distribution of S. pneumoniae from UAD and culture isolates.
2) The incidence rate of CAP and SP+-CAP in geographic locations in which a population denominator can be determined.
3) Antimicrobial drug resistance rates of S. pneumoniae isolates.
4) Differences in detection rate of S. pneumoniae among culture test, BinaxNOW® and UAD assay.
5) The incidence rate of COP and pneumococcal pneumonia in geographical locations in which a population denominator can be determined for the calculation of the incidence rates.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in the study:
1) Age: 18 years old and above
2) Inpatient/outpatient: Both are acceptable
3) Residents living in Goto islands
4) Diagnosed as pneumonia clinically and having at least two of the following signs/symptoms compatible with pneumonia:
*Cough (either productive or dry)
*Purulent sputum
*Abnormal findings in auscultation and/or percussion (moist rales, respiratory sound attenuation, abnormal dullness in percussion, etc.)
*Dyspnea and/or tachypnea
*Fever (measured axillary temperature of >= 37oC)
*WBC >10,000/mm3, or >15% bands, or WBC <4,500/mm3
*Elevated CRP value (over the upper limit of institutional reference value)
*Hypoxemia (PaO2 <60 Torr, or SpO2 <90%)
5) Showing a pneumonia pattern(e.g. alveolar infiltrative shadow associated with air bronchogram)on chest X-ray or chest CT
6) Able and willing to provide urine and blood

Key exclusion criteria

1) Any subject who is transferred to a participating medical institution after already being hospitalized for 48 hours or more at any other hospital
2) Hospital acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more)
3) Subjects with either pneumococcal vaccine (PPV23 and/or PCV13) within the past 30 days
4) Previous enrollment in this study within the past 30 days

Target sample size

3300

Name of lead principal investigator

1st name	Taiga
Middle name
Last name	Miyazaki

Organization

Nagasaki University Hospital

Division name

Second Department of Internal Medicine

Zip code

852-8501

Address

1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.

TEL

095-819-7273

Email

taiga-m@nagasaki-u.ac.jp

Name of contact person

1st name	Taiga
Middle name
Last name	Miyazaki

Organization

Nagasaki evaluation organization for clinical interventions

Division name

office

Zip code

103-0007

Address

3-35-5, Nihonbashihamacho, Chuou-ku, Tokyo

TEL

03-3527-2020

Homepage URL

Email

jimukyoku@neoci.or.jp

Institute

Nagasaki evaluation organization for clinical interventions

Institute

Department

Personal name

Organization

Pfizer Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

General Affairs Division

Address

1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.

Tel

095-819-7217

Email

mh_shomu@ml.nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

・長崎県五島中央病院（長崎県）
・宗教法人お告げのマリア修道会　聖マリア病院（長崎県）
・長崎県富江病院（長崎県）
・医療法人社団厚善会　郡家病院（長崎県）
・長崎県五島中央病院附属診療所　奈留医療センター（長崎県）
・五島市国民健康保険　三井楽診療所（長崎県）
・医療法人　井上内科小児科医院（長崎県）
・医療法人雄仁会　浦クリニック（長崎県）
・久保循環器内科（長崎県）
・医療法人　みどりが丘クリニック（長崎県）
・宿輪医院（長崎県）
・医療法人　山内診療所山内診療所、川原診療所（長崎県）
・医療法人健友会　五島ふれあい診療所（長崎県）
・いけだ内科（長崎県）
・介護老人保健施設　リハビリセンターふくえ（長崎県）
・五島市国民健康保険　玉之浦診療所（長崎県）
・介護老人保健施設　五島福寿園（長崎県）
・富江診療所（長崎県）
・南町脳神経外科クリニック（長崎県）
・虎島医院（長崎県）

Date of disclosure of the study information

2015

Year

11

Month

30

Day

URL releasing protocol

https://www.chestpulmonary.org

Publication of results

Published

URL related to results and publications

https://www.chestpulmonary.org

Number of participants that the trial has enrolled

2103

Results

A total of 2,103 patients with CAP were enrolled; 84% were aged 65 years or older and 6.7% died during the study. The annual CAP, S pneumoniae CAP, 13-valent pneumococcal conjugate vaccine (PCV13) serotype CAP, and PCV20 serotype CAP incidences per 100,000 population were 1,280, 227, 63, and 110, respectively. S pneumoniae was detected in 17.8% of all patients with CAP by any detection method, with 4.9%, 5.5%, and 8.6% of cases of CAP resulting from PCV13, PCV15, and PCV20 serotypes, respectively.

Results date posted

2023

Year

08

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The mean age at consent was 77.6 years, 1,765 patients (83.9%) were aged 65 years or older, and 53.9% were female. The mean pneumonia severity index (PSI) score on admission was 108.9, with 39.0% and 28.6% of patients having class IV or V PSI scores, respectively. In total, 70.7% of all patients were hospitalized; the mean hospital stay duration was 14.1 days. Mortality during the study was 6.7% (141/2,103), and in-hospital mortality was 6.2% (130/2,103). Among patients who died, 94.3% (133/141) were aged 65 years or older and 5.7% (8/141) were 18 to 64 years of age.

Participant flow

Study participants were recruited between December 2015 and November 2020. All health care facilities in Goto City, including four hospitals and 25 outpatient clinics, were include in the study. Residents aged 18 years or older in Goto City, Japan, with suspected CAP were screened at all hospitals and outpatient clinics. Of 2,105 patients screened, 2,103 patients were eligible and included in the analysis population. Two screened patients were not included in the analysis because the radiographic findings were not compatible with CAP.

Adverse events

N/A

Outcome measures

Incidences of CAP and S pneumoniae CAP among Japanese adults

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

10

Month

13

Day

Date of IRB

2015

Year

03

Month

27

Day

Anticipated trial start date

2015

Year

12

Month

01

Day

Last follow-up date

2020

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

･Research Design
This is a prospective, multicenter, active surveillance, cohort study. Residents aged 18 years or older in Goto City who present to the relevant hospital departments/emergency rooms/clinics with signs and symptoms of pneumonia and have radiographic evidence of pneumonia, as read by the treating health care provider or radiologist will be prospectively identified and enrolled. There will be no treatment interventions in the study. As this is an active, prospective surveillance study, sites should screen all subjects presenting to relevant hospital locations (e.g. emergency room, hospital outpatient departments, inpatient wards, etc.) who may meet the inclusion/exclusion criteria on a 24 hour basis for enrollment. This study is a population-based surveillance in which research-participating medical institutions cover the entire population of the southern part of Goto Islands (Goto City).

･Subject Collection Method
All patients who get the medical care at each participating medical institution in the period from December 1, 2015 to November 30, 2020, and meet the inclusion criteria.

･Endpoints
Primary endpoint
1. The overall proportion of subjects with clinically and radiographically-confirmed CAP who have any pneumococcal serotype in PCV13 detected by either UAD assay and/or culture.

Secondary endpoints
1. The serotype distribution of S. pneumoniae from UAD and culture isolates.
2. The incidence rate of CAP and SP+-CAP in geographic locations in which a population denominator can be determined.
3. Antimicrobial drug resistance rates of S. pneumoniae isolates.
4. Differences in detection rate of S. pneumoniae among culture test, BinaxNOW&reg; , and UAD assay.
5. The incidence rates of COP and pneumococcal pneumonia in geographical locations in which a population denominator can be determined for the calculation of the incidence rates.

Registered date

2015

Year

11

Month

27

Day

Last modified on

2023

Year

08

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023045