PneumoniaOSPISNCT03606135
Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)
An observational study of Pneumonia, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- The Pneumonia Group
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 17 Sep 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Signed and dated informed consent.
- Age ≥ 18 years.
- Able and willing to provide urine sample.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pneumonia
- Being tested
- The Pneumonia Group, The Control Group
- Keywords
- Pneumonia, Streptococcus pneumoniae, Incidence, Ethiology, Serotype
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Pneumonia GroupOther
The Control GroupOther
| Study group | Role | What they receive |
|---|---|---|
| The Pneumonia Group | Subjects with chest images (x-ray or CT scan) indicating pneumonia. Receives: Other: The Pneumonia Group | |
| The Control Group | Healthy subjects Receives: Other: The Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (6)
The S.pneumoniae serotype distribution form UAD and culture isolates.
The full distribution of all S.pneumoniae serotypes among patients with CAP.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 10 days
Antibiotic resistance rates among isolates of S.pneumoniae
Antibiotic resistance rates among isolates of S.pneumoniae.
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start17 Sep 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jonas Ahl, MD, PhD, Principal investigator, Department of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606135
- Sponsor's protocol ID
- 2016/220
- Acronym
- OSPIS
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2018
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hansen K, Yamba Yamba L, Wasserstrom L, Runow E, Goransson T, Nilsson A, Ahl J, Riesbeck K. Exploring the microbial landscape: uncovering the pathogens associated with community-acquired pneumonia in hospitalized patients. Front Public Health. 2023 Dec 13;11:1258981. doi: 10.3389/fpubh.2023.1258981. eCollection 2023.
PubMed 38152664
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP) in Adults ≥ 18 Years (OSPIS)
- ClinicalTrials.gov ID
- NCT03606135
- Acronym / sponsor ID
- OSPIS / 2016/220
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Streptococcus pneumoniae, Incidence, Ethiology, Serotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Pneumonia Group | – | Other: The Pneumonia GroupSubjects with chest images (x-ray or CT scan) indicating pneumonia. |
| The Control Group | – | Other: The Control GroupHealthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Pneumonia Group | Other | The Pneumonia Group |
| The Control Group | Other | The Control Group |
Primary outcome
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.
6 secondary outcomes
The S.pneumoniae serotype distribution form UAD and culture isolates.
Time frame: 10 days
The incidence rate of CAP and subjects with S.pneumoniae positive radiologically confirmed CAP (SP+CAP)
Time frame: 10 days
The differences in detection of S.pneumoniae by culture, BinaxNOW® and the UAD assay
Time frame: 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
Antibiotic resistance rates among isolates of S.pneumoniae
Time frame: 10 days
Validation of the UAD assay in CAP patients and compare with controls
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 38152664Hansen K, Yamba Yamba L, Wasserstrom L, Runow E, Goransson T, Nilsson A, Ahl J, Riesbeck K. Exploring the microbial landscape: uncovering the pathogens associated with community-acquired pneumonia in hospitalized patients. Front Public Health. 2023 Dec 13;11:1258981. doi: 10.3389/fpubh.2023.1258981. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Ahl, MD, PhD principal investigator
Department of Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.