Pneumococcal DiseaseB1851065NCT01564771
Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
An observational study of Pneumococcal Disease, run by Pfizer at 21 sites in Greece.
Trial summary
Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- Non Intervention
- How many people
- 293 participants
- Where
- 21 sitesGreece
- Study dates
- Jan 2011to Apr 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults ≥18 years of age with chest X-ray confirmed CAP
Who may be able to join
- Patients who agreed to participate in the study and agreed to sign an ICD.
- Patients had to be ≥18 years of age (adults)
- Patients had to present or had been referred to a participating healthcare facility with suspected pneumonia based on the physician's assessment (including but not limited to specific signs and symptoms described in Section 9.3 of the protocol)
- Patients must have had a posteroanterior or anteroposterior chest X-ray showing an infiltrate (if previous films were not available) or a new infiltrate (if recent film was available)
- Patients had to be tested positive for the Binax NOW® assay (required post Protocol Amendment 2)
Who cannot join
- Patients who did not sign an ICD.
- Any patient who developed signs and symptoms of pneumonia after being hospitalized for ≥48 hours
- Any patient who was transferred to a study healthcare facility after already being hospitalized for ≥48 hours at another healthcare facility
- Patients who did not have a chest X-ray performed
- Patients who did not have the Binax NOW® assay performed
- Patients with negative results for the Binax NOW® assay (required post Protocol Amendment 2)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Greece21 sites
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
General University Hospital of Alexandroupoli
Alexandroupoli, 68100
General Hospital of Athens "Evangelismos" / Pneumonology Department
Athens, Attica
General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine
Athens, 11527
General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic
Athens, 11527
General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic
Athens, 11527
General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic
Athens, 11527
General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic
Athens, 11527
General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic
Athens, 11527
General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic
Athens, 11527
Diagnostic Therapeutic Center of Athens Ygeia
Athens, 15123
General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic
Athens, 15126
General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department
Athens, 15126
General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic
Athens, 15126
General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic
Athens, 15127
General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department
Athens, 15127
Sotiria Hospital, Intensive Care Unit
Athens, 15227
General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med
Athnens
General Hospital of Kavala/ A Pneumonological Clinic
Kavala, 65201
General Hospital of Kavala/ b Pneumonological & Tubeculosis Department
Kavala, 65201
University General Hospial of Larissa, Pneumonology Department
Larissa, 41 110
About this study
Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying medical reasons which necessitate inpatient care. It is also probable that the real burden of pneumococcal disease is not well estimated especially among adults. New additions in the laboratory setting such as the pneumococcal urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be helpful in identifying more pneumococcal infections compared to the previous years. This NIS is based on the unmet scientific need to describe the serotype distribution and the resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.
Read the detailed description
For each surveillance period lasting for 12 months all adults presenting in the selected clinics with symptoms and signs suggestive of pneumonia (candidate cases) will be asked to participate in the study
- Conditions
- Pneumococcal Disease
- Being tested
- Non Intervention
- Keywords
- Pneumococcal serotypes, Community Acquired Pneumonia (CAP)
- Medical subject headings
- Pneumococcal Infections, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionOther
This Is A Non Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Group one | Adults ≥18 years of age with chest X-ray confirmed CAP Receives: Other: Non Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of serotypes 4,6B,9V,14,18C,19F,23F,1,3,5,6A,7F and 19A from chest X-ray confirmed pCAP patients (post amendment2 with positive Binax NOW® only) who presented in the emergency departments of 15 hospitals in Greece during 1
Measured: One year
calendar year.
Measured: One year
Secondary outcomes (2)
Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.
Measured: One year
The frequency of the 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, 19A serotypes (based on Luminex assay) of study patients immunized and not immunized with PPV.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 293 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
- NCT01564771
- Sponsor's protocol ID
- B1851065
- Acronym
- B1851065
- Status last verified
- Nov 2018
- First submitted
- 26 Mar 2012
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
- ClinicalTrials.gov ID
- NCT01564771
- Acronym / sponsor ID
- B1851065 / B1851065
- Conditions
- Pneumococcal Disease
- Keywords
- Pneumococcal serotypes, Community Acquired Pneumonia (CAP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Mar 2012 (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.
Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying medical reasons which necessitate inpatient care. It is also probable that the real burden of pneumococcal disease is not well estimated especially among adults. New additions in the laboratory setting such as the pneumococcal urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be helpful in identifying more pneumococcal infections compared to the previous years. This NIS is based on the unmet scientific need to describe the serotype distribution and the resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.
Detailed description
For each surveillance period lasting for 12 months all adults presenting in the selected clinics with symptoms and signs suggestive of pneumonia (candidate cases) will be asked to participate in the study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group one | – | Other: Non InterventionAdults ≥18 years of age with chest X-ray confirmed CAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ≥18 years of age with chest X-ray confirmed CAP
Key inclusion criteria (5 listed)
- Patients who agreed to participate in the study and agreed to sign an ICD.
- Patients had to be ≥18 years of age (adults)
- Patients had to present or had been referred to a participating healthcare facility with suspected pneumonia based on the physician's assessment (including but not limited to specific signs and symptoms described in Section 9.3 of the protocol)
- Patients must have had a posteroanterior or anteroposterior chest X-ray showing an infiltrate (if previous films were not available) or a new infiltrate (if recent film was available)
- Patients had to be tested positive for the Binax NOW® assay (required post Protocol Amendment 2)
Key exclusion criteria (6 listed)
- Patients who did not sign an ICD.
- Any patient who developed signs and symptoms of pneumonia after being hospitalized for ≥48 hours
- Any patient who was transferred to a study healthcare facility after already being hospitalized for ≥48 hours at another healthcare facility
- Patients who did not have a chest X-ray performed
- Patients who did not have the Binax NOW® assay performed
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 |
|---|---|---|
| Non InterventionThis Is A Non Interventional Study | Other | Group one |
Primary outcome
The frequency of serotypes 4,6B,9V,14,18C,19F,23F,1,3,5,6A,7F and 19A from chest X-ray confirmed pCAP patients (post amendment2 with positive Binax NOW® only) who presented in the emergency departments of 15 hospitals in Greece during 1
Time frame: One year
calendar year.
Time frame: One year
2 secondary outcomes
Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.
Time frame: One year
The frequency of the 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, 19A serotypes (based on Luminex assay) of study patients immunized and not immunized with PPV.
Time frame: One year
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 Dec 2018.
- 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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Pfizer at 21 sites in Greece.
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 5 inclusion and 6 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Greece. 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 frequency of serotypes 4,6B,9V,14,18C,19F,23F,1,3,5,6A,7F and 19A from chest X-ray confirmed pCAP patients (post amendment2 with positive Binax NOW® only) who presented in the emergency departments of 15 hospitals in Greece during 1 (time frame: One year). The study lists 2 primary outcomes in all. 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 3 Dec 2018.