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.

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. - 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019961

Enrollment

3300

Registered

2015-11-30

Start date

2015-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia(CAP)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 rate of COP and pneumococcal pneumonia in geographical locations in which a population denominator can be determined for the calculation of the incidence rates.	—

Measure

Time frame

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 rate of COP and pneumococcal pneumonia in geographical locations in which a population denominator can be determined for the calculation of the incidence rates.

—

Countries

Japan

Contacts

Public ContactTaiga Miyazaki

Nagasaki evaluation organization for clinical interventions office

jimukyoku@neoci.or.jp03-3527-2020

Outcome results