Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year. (B1851065)

Pfizer

Status: Completed

Conditions: Pneumococcal Disease

Treatments: Other: Non Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01564771

B1851065

Details and patient eligibility

About

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.

Full 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

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

293 participants in 1 patient group

Group one

Description:

Adults ≥18 years of age with chest X-ray confirmed CAP

Treatment:

Other: Non Intervention