Community Acquired PneumoniaNCT00929721
A Global Active Surveillance for Community Acquired Pneumonia
A study testing Blood draw, Chest X-ray and urine specimen in people with Community Acquired Pneumonia, run by Pfizer at 1 site in Poland.
Trial summary
This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Blood draw, Chest X-ray and urine specimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,172 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2009to Feb 2012
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects 50 years of age or older
- Subject must reside in the surveillance area
- Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP
Who cannot join
- Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital).
- Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older
This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Blood draw, Chest X-ray, urine specimen, Nasopharyngeal swab, sputum
- Keywords
- CAP
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Also called Blood stick
culture for Streptococcus pneumoniae Frequency-1
Chest X-rayProcedure or surgery
Also called Picture of lungs
image of the lungs to assess changes consistent with pneumonia Frequency-1
urine specimenProcedure or surgery
Also called urine dipstick test
assay for the presence of Streptococcus pneumoniae Binax and UAD
Nasopharyngeal swabProcedure or surgery
Also called swab from inside the nose and throat
culture for Streptococcus pneumoniae Frequency-1
sputumProcedure or surgery
Also called collection secretions produced during cough
culture for Streptococcus pneumoniae Frequency-1
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Community-Acquired Pneumonia | Other | Subjects with Community-Acquired Pneumonia Receives: Procedure: Blood draw; Procedure: Chest X-ray; Procedure: urine specimen; Procedure: Nasopharyngeal swab; Procedure: sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of CAP in adults 50 years and older
Measured: up to 120 days from enrollment
Secondary outcomes (1)
Frequency of bacterial agents associated with CAP, Case fatality and incidence rates of CAP number and characteristics of subjects from outpatient clinics, emergency rooms, and hospital in-patient departments
Measured: up to 120 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929721
- Sponsor's protocol ID
- 6115A1-4000
- Status last verified
- Apr 2012
- First submitted
- 26 Jun 2009
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Active Surveillance for Community-Acquired Pneumonia (CAP) in Adults 50 Years and Older
- ClinicalTrials.gov ID
- NCT00929721
- Acronym / sponsor ID
- 6115A1-4000
- Conditions
- Community Acquired Pneumonia
- Keywords
- CAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,172 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Jun 2009 (estimated)
- 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 study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Community-Acquired Pneumonia | Other | Procedure: Blood draw, Procedure: Chest X-ray, Procedure: urine specimen, Procedure: Nasopharyngeal swab, Procedure: sputumSubjects with Community-Acquired Pneumonia |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects 50 years of age or older
- Subject must reside in the surveillance area
- Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP
Key exclusion criteria (2 listed)
- Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital).
- Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).
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 |
|---|---|---|
| Blood drawAlso: Blood stickculture for Streptococcus pneumoniae Frequency-1 | Procedure or surgery | Subjects with Community-Acquired Pneumonia |
| Chest X-rayAlso: Picture of lungsimage of the lungs to assess changes consistent with pneumonia Frequency-1 | Procedure or surgery | Subjects with Community-Acquired Pneumonia |
| urine specimenAlso: urine dipstick testassay for the presence of Streptococcus pneumoniae Binax and UAD | Procedure or surgery | Subjects with Community-Acquired Pneumonia |
| Nasopharyngeal swabAlso: swab from inside the nose and throatculture for Streptococcus pneumoniae Frequency-1 | Procedure or surgery | Subjects with Community-Acquired Pneumonia |
| sputumAlso: collection secretions produced during coughculture for Streptococcus pneumoniae Frequency-1 | Procedure or surgery | Subjects with Community-Acquired Pneumonia |
Primary outcome
Incidence rates of CAP in adults 50 years and older
Time frame: up to 120 days from enrollment
1 secondary outcome
Frequency of bacterial agents associated with CAP, Case fatality and incidence rates of CAP number and characteristics of subjects from outpatient clinics, emergency rooms, and hospital in-patient departments
Time frame: up to 120 days from enrollment
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 13 Apr 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw, Chest X-ray and urine specimen in people with Community Acquired Pneumonia, run by Pfizer at 1 site in Poland.
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 3 inclusion and 2 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 13 Apr 2012. 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 Poland. 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?
Incidence rates of CAP in adults 50 years and older (time frame: up to 120 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2012; AzTrials last refreshed its copy on 6 Nov 2026.