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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: The Pneumonia Group; Other: The Control Group

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Skane University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Pneumonia Group: Adults ≥ 18 years of age who present to the emergency room with signs and symptoms of CAP and have radiographic evidence of pneumonia, as read by the clinical radiologist on duty will be identified and enrolled. As this is an active, prospective surveillance study, all eligible subjects should be screened for enrolment, including whose who are admitted during nights.

The Control Group: Subjects will be sceened by the nurse at the orthopedic section of the emergency unit, since these patients are unlikely to have respiratory tract infections. Subjects will be chosen randomly and evenly over the whole duration of the study to get a representative control group.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The Pneumonia Group; Subjects with chest images (x-ray or CT scan) indicating pneumonia.	Other: The Pneumonia Group
The Control Group; Healthy subjects	Other: The Control Group

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of different microbial findings in subjects with CAP including the proportion of co-infection and correlate with severity of disease	To define the distribution of different microbial findings in subjects with CAP and estimate viral and bacterial load using semi-quantitive PCR and correlate it with severity of disease and calculate the proportion of subjects with co-infection.	10 days
Difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR	To define the difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR (Polymerase Chain Reaction).	10 days
Distribution of nasopharyngeal microbial findings in subjects with CAP in comparison to an asymptomatic control group	To determine differences in nasopharyngeal microbial findings in subjects with CAP and an asymptomatic control group.	10 days
The microbiome in the respiratory tract in subjects initially diagnosed with CAP and after 3 months. The control group will be included.	To determine the microbiome in the respiratory tract in subjects diagnosed with CAP and compare those microbiomes 3 months later. CAP subjects will be compared with the control group.	3 months
Antibiotic resistance rate of bacterial isolates	To estimate antibiotic resistance rates among bacterial isolates, other than S.pneumoniae.	10 days
Correlation of antibiotic regimen, clinical outcome and readmission	To calculate the correlation of antibiotic regimen, ICU, length-of-stay (LOS) and clinical outcome including mortality after 90 days in addition to readmission rate.	3 months
Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65, and Pneumonia Severity Index	Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65 (Confusion-Rate-Blood pressure, ≥65 years) and Pneumonia Severity Index	3 months
Correlation between treatment with protein pump inhibitors and CAP	To observe any correlation between CAP and treatment with protein pump inhibitors.	10 days
Correlation of the levels of vitamin D and severity of CAP	To correlate levels of vitamin D to severity of CAP	10 days
New cognitive impairment at follow-up	To determine which factors of MoCA (Montreal Cognitive Assessment) are associated with long-term cognitive impairment after hospitalization with pneumonia.	3 months
Newly acquired functional disability of performing physical activities at follow-up	To determine which factors of P-ADL (Physical Activities of Daily Living) are associated with functional decline after pneumonia.	3 months
Newly acquired functional disability of performing instrumental activities at follow-up	To determine which factors of I-ADL (Instrumental Activities of Daily Living) are associated with functional decline after pneumonia.	3 months
Decline in quality of life from enrolment to follow-up	To determine which factors of EQ-5D (European Quality of life - 5 Dimensions) are associated with declining quality of life after pneumonia.	3 months

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Pfizer
• Investigators: Principal Investigator: Jonas Ahl, MD, PhD, Department of Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pneumonia; Incidence; Streptococcus pneumoniae; Serotype; Ethiology
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 2016/220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No