Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01564771
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2012-03-26
Brief Title:
Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece Over 1 Year
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece Over 1 Year
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B1851065
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None