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

Completed

• Conditions: Pneumonia
• Interventions: Other: The Pneumonia Group; Other: The Control Group

• Registration Number: NCT03606135
• Lead Sponsor: Region Skane

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-17
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-30
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Pneumonia Group	The Pneumonia Group	Subjects with chest images (x-ray or CT scan) indicating pneumonia.
The Control Group	The Control Group	Healthy subjects

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Malmö, Sweden