Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
B1851065
1 other identifier
observational
293
1 country
21
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedDecember 3, 2018
November 1, 2018
2.2 years
March 26, 2012
November 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
One year
calendar year.
One year
Secondary Outcomes (2)
Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.
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.
One year
Study Arms (1)
Group one
Adults ≥18 years of age with chest X-ray confirmed CAP
Interventions
Eligibility Criteria
Adults ≥18 years of age with chest X-ray confirmed CAP
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (21)
General Hospital of Athens "Evangelismos" / Pneumonology Department
Athens, Attica, Greece
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
General University Hospital of Alexandroupoli
Alexandroupoli, 68100, Greece
General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic
Athens, 11527, Greece
General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic
Athens, 11527, Greece
Diagnostic Therapeutic Center of Athens Ygeia
Athens, 15123, Greece
General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic
Athens, 15126, Greece
General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department
Athens, 15126, Greece
General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic
Athens, 15126, Greece
General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic
Athens, 15127, Greece
General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department
Athens, 15127, Greece
Sotiria Hospital, Intensive Care Unit
Athens, 15227, Greece
General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med
Athnens, Greece
General Hospital of Kavala/ A Pneumonological Clinic
Kavala, 65201, Greece
General Hospital of Kavala/ b Pneumonological & Tubeculosis Department
Kavala, 65201, Greece
University General Hospial of Larissa, Pneumonology Department
Larissa, 41 110, Greece
Related Links
Biospecimen
Urine Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2012
First Posted
March 28, 2012
Study Start
January 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
December 3, 2018
Record last verified: 2018-11