Prospective Surveillance Study on Adult Pneumococcal Pneumonia in Japan

JRCT ID: jRCT1030240518

Registered date:03/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Community-acquired pneumonia
• Date of first enrollment: 03/12/2024
• Target sample size: 1200
• Study type: Observational

Outcome(s)

Primary Outcome

- To describe the demographic and clinical characteristics of adults >=18 years old hospitalized with either non-pneumococcal or pneumococcal community-acquired pneumonia (CAP), including both bacteremic and non-bacteremic pneumococcal CAP.
- To determine the prevalence of pneumococcal serotypes included in the pneumococcal conjugated vaccines in adults >=18 years old hospitalized with pneumococcal CAP.
- To assess in-hospital clinical outcome including in-hospital mortality, ICU admission, and length of hospitalization in adults >=18 years old hospitalized with pneumococcal CAP, including both bacteremic and non-bacteremic pneumococcal CAP.

• Secondary Outcome: To describe the hospital specific incidence of bacteremic and non-bacteremic pneumococcal CAP.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1. Adults aged >=18 years.
2. Clinical signs and/or symptoms of an acute respiratory illness, as defined by >=1 of the following:
- New or worsening shortness of breath in the past 7 days
- New or worsening cough in the past 7 days
- New or worsening sputum production in the past 7 days
- New or worsening chest pain in the past 7 days
- Tachypnea to respiratory rate >=22 breaths/min not known to be chronic
- Hypoxia to SpO2 <= 92 percent not known to be chronic
- Initiation of invasive or non-invasive mechanical ventilation
3. Clinical signs and/or symptoms of an acute infection, as defined by >=1 of the following:
- Sublingual body temperature >=37.5 C (99.5 F) or <=35.5 C (95.9 F)
- Reported fever, chills, or feeling feverish at home without explicit documentation of a fever within the past 7 days
- White blood cell count >10.7 or <3.9 thousand cells/mcL
- C-reactive protein >10 mg/L
- Altered mental status
4. Radiologic evidence of pneumonia interpreted by a radiologist, defined as >=l of the following findings on chest x-ray (CXR) or computed tomography (CT) completed in the outpatient setting or within 72 hours before or after hospital admission:
- Pulmonary infiltrate not known to be chronic
- Pulmonary opacity not known to be chronic (including ground glass opacities on CT)
- Pulmonary consolidation not known to be chronic
5. Patients willing and able to give informed consent written in Japanese for participation in the study.

Exclude criteria

- Enrollment in this study within the past 30 days.
- Development of pneumonia (as defined in the inclusion criteria) more than 48 hours after hospital admission (pneumonia developed 48 hours after admission will be considered HAP).
- Inability to obtain consent from patient or surrogate for this study within 72 hours of hospital admission (including time at a transferring hospital prior to admission at a study hospital).
- Inability or unwillingness of the patient to provide a urine sample within 72 hours of hospital admission (including time at a transferring hospital prior to admission at a study hospital) or the patient is not able or unwilling to provide a urine sample at the day when patient is diagnosed with PP in outpatient clinic.
- Non-pneumonia illness completely explains the acute symptoms. Alternative non-pneumonia illnesses could include: pulmonary embolism, acute heart failure, lung cancer, and pulmonary hemorrhage.

Related Information

• Primary Sponsor: Matsuki Taizo
• Source(s) of Monetary Support: MSD K.K.