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

Pneumonia Clinical Trial

— OSPIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606135
• Other study ID #: 2016/220
• Status: Completed
• Start date: September 17, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• The Pneumonia Group

• The Control Group

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Antibiotic resistance rate of bacterial isolates	To estimate antibiotic resistance rates among bacterial isolates, other than S.pneumoniae.	10 days
Other	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
Other	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
Other	Correlation between treatment with protein pump inhibitors and CAP	To observe any correlation between CAP and treatment with protein pump inhibitors.	10 days
Other	Correlation of the levels of vitamin D and severity of CAP	To correlate levels of vitamin D to severity of CAP	10 days
Other	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
Other	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
Other	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
Other	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
Primary	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	The S.pneumoniae serotype distribution form UAD and culture isolates.	The full distribution of all S.pneumoniae serotypes among patients with CAP.	10 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Antibiotic resistance rates among isolates of S.pneumoniae	Antibiotic resistance rates among isolates of S.pneumoniae.	10 days
Secondary	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