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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-17

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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The Pneumonia Group

Subjects with chest images (x-ray or CT scan) indicating pneumonia.

The Pneumonia Group

Intervention Type OTHER

The Control Group

Healthy subjects

The Control Group

Intervention Type OTHER

Interventions

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The Pneumonia Group

Intervention Type OTHER

The Control Group

Intervention Type OTHER

Eligibility Criteria

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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

* Signed and dated informed consent.
* Age ≥ 18 years.
* Able and willing to provide urine sample.

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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes