Clinical trial NCT03606135: Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)
Official title: Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ≥ 18 Years (OSPIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Pneumonia
Streptococcus pneumoniae
Incidence
Ethiology
Serotype
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-07-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion S.pneumoniae serotypes included in PCV13 (Pneumococcal conjugate vaccine) among adults ≥18 years of age presenting with radiographically-confirmed CAP.
timeFrame: 10 days
Secondary outcomes:
measure: The S.pneumoniae serotype distribution form UAD and culture isolates.
timeFrame: 10 days
measure: The incidence rate of CAP and subjects with S.pneumoniae positive radiologically confirmed CAP (SP+CAP)
timeFrame: 10 days
measure: The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay
timeFrame: 10 days
measure: The proportion of subjects with CAP and with SP+CAP who present with underlying at-risk and high-risk medical conditions
timeFrame: 10 days
measure: Antibiotic resistance rates among isolates of S.pneumoniae
timeFrame: 10 days
measure: Validation of the UAD assay in CAP patients and compare with controls
timeFrame: 10 days
Other outcomes:
measure: Distribution of different microbial findings in subjects with CAP including the proportion of co-infection and correlate with severity of disease
timeFrame: 10 days
measure: Difference in sensitivity in detection of bacterial agents, comparing sputum and nasopharyngeal sampling and comparing bacterial culture with PCR
timeFrame: 10 days
measure: Distribution of nasopharyngeal microbial findings in subjects with CAP in comparison to an asymptomatic control group
timeFrame: 10 days
measure: The microbiome in the respiratory tract in subjects initially diagnosed with CAP and after 3 months. The control group will be included.
timeFrame: 3 months
measure: Antibiotic resistance rate of bacterial isolates
timeFrame: 10 days
measure: Correlation of antibiotic regimen, clinical outcome and readmission
timeFrame: 3 months
measure: Etiology and and outcome in patients with CAP and correlate it to the Charlson Comorbidity Index, CRB-65, and Pneumonia Severity Index
timeFrame: 3 months
measure: Correlation between treatment with protein pump inhibitors and CAP
timeFrame: 10 days
measure: Correlation of the levels of vitamin D and severity of CAP
timeFrame: 10 days
measure: New cognitive impairment at follow-up
timeFrame: 3 months
measure: Newly acquired functional disability of performing physical activities at follow-up
timeFrame: 3 months
measure: Newly acquired functional disability of performing instrumental activities at follow-up
timeFrame: 3 months
measure: Decline in quality of life from enrolment to follow-up
timeFrame: 3 months
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Department of Infectious Diseases
name: Jonas Ahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: