Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)

Study Overview
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Brief Summary
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This is an epidemiological study to investigate the etiology of radiographically-confirmed community-acquired pneumonia (CAP) in adults aged ≥18 years. The main objective is to determine the proportion of which cases that is due to Streptococcus pneumoniae and the corresponding incidence and serotype distribution. The study will utilize a serotype-specific urinary antigen detection (UAD) assay.

Official Title
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Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ≥ 18 Years (OSPIS)

Conditions
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Pneumonia

Intervention / Treatment
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* Other: The Pneumonia Group
* Other: The Control Group


Participation Criteria
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Eligibility Criteria
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The Pneumonia Group Inclusion Criteria: Age ≥ 18 years. Present to a study healthcare facility where treating physician clinically suspects CAP with the presence of two or more of the following signs and symptoms: Fever, Hypothermia, Chills or rigors, Pleuritic chest pain, Cough, Sputum production, Dyspnea, Tachypnea, Malaise, Abnormal auscultatory findings suggestive of pneumonia. Has radiographic finding that is consistent with pneumonia. Able and willing to provide urine sample. Signed and dated informed consent Exclusion Criteria: Transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility. Hospital acquired pneumonia. Subjects who are investigational staff members and their family members, and site staff members otherwise supervised by the investigator. Previous enrollment in this study within the previous 30 days. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study. The Control Group Inclusion Criteria: Signed and dated informed consent. Age ≥ 18 years. Able and willing to provide urine sample. Exclusion Criteria: Subjects who are investigational staff members or relatives of those staff member or subjects who are Pfizer employees directly involved in the conduct of the study. Subjects with suspicion of CAP or any other respiratory infectious disease, as well as evidence of or documented concomitant infectious disease. Subjects residing in any long-term care facilities. Subjects with known bronchial obstruction or history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has no been an exacerbation with 3 months prior to enrollment. Subjects with primary lung cancer or another malignancy metastatic to the lungs. Subjects with fever. Subjects with significant immunosuppressive disease such as AIDS, leukemia, etc. Subjects with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The Pneumonia Group<br>Subjects with chest images (x-ray or CT scan) indicating pneumonia. | Other: The Pneumonia Group<br> <br> |
| The Control Group<br>Healthy subjects | Other: The Control Group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion S.pneumoniae serotypes included in PCV13 (Pneumococcal conjugate vaccine) among adults ≥18 years of age presenting with radiographically-confirmed CAP. | The overall proportion of subjects with clinically and radiographically-confirmed CAP who have PCV13 S.pneumoniae detected by either UAD assay and/or culture. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The S.pneumoniae serotype distribution form UAD and culture isolates. | The full distribution of all S.pneumoniae serotypes among patients with CAP. | 10 days | 
| The incidence rate of CAP and subjects with S.pneumoniae positive radiologically confirmed CAP (SP+CAP) | The incidence rate of CAP and SP+CAP | 10 days | 
| The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay | The overall proportion of SP+CAP subjects with S.pneumoniae identified by culture, BinaxNOW®, and/or either UAD assay. | 10 days | 
| The proportion of subjects with CAP and with SP+CAP who present with underlying at-risk and high-risk medical conditions | The proportion of subjects with CAP and SP+CAP who present with underlying at-risk and high-risk medical conditions. | 10 days | 
| Antibiotic resistance rates among isolates of S.pneumoniae | Antibiotic resistance rates among isolates of S.pneumoniae. | 10 days | 
| Validation of the UAD assay in CAP patients and compare with controls | To validate the UAD assay in CAP patients and compare results with the control group. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethiology, Incidence, Serotype, Pneumonia, Streptococcus pneumoniae