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

April 2, 2020 updated by: Region Skane

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The S.pneumoniae serotype distribution form UAD and culture isolates.
Time Frame: 10 days
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)
Time Frame: 10 days
The incidence rate of CAP and SP+CAP
10 days
The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
Antibiotic resistance rates among isolates of S.pneumoniae.
10 days
Validation of the UAD assay in CAP patients and compare with controls
Time Frame: 10 days
To validate the UAD assay in CAP patients and compare results with the control group.
10 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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.
Time Frame: 3 months
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
Time Frame: 10 days
To estimate antibiotic resistance rates among bacterial isolates, other than S.pneumoniae.
10 days
Correlation of antibiotic regimen, clinical outcome and readmission
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 10 days
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
Time Frame: 10 days
To correlate levels of vitamin D to severity of CAP
10 days
New cognitive impairment at follow-up
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonas Ahl, MD, PhD, Department of Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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