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

NCT ID: NCT01564771

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 293 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-04-30

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

Conditions

Pneumococcal Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group one

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

Non Intervention

Intervention Type: OTHER

This Is A Non Interventional Study

Interventions

Non Intervention

This Is A Non Interventional Study

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

General Hospital of Athens "Evangelismos" / Pneumonology Department

Athens, Attica, Greece

University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

General University Hospital of Alexandroupoli

Alexandroupoli, , Greece

General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine

Athens, , Greece

General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic

Athens, , Greece

Diagnostic Therapeutic Center of Athens Ygeia

Athens, , Greece

General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic

Athens, , Greece

General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department

Athens, , Greece

General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic

Athens, , Greece

General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic

Athens, , Greece

General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department

Athens, , Greece

Sotiria Hospital, Intensive Care Unit

Athens, , Greece

General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med

Athnens, , Greece

General Hospital of Kavala/ A Pneumonological Clinic

Kavala, , Greece

General Hospital of Kavala/ b Pneumonological & Tubeculosis Department

Kavala, , Greece

University General Hospial of Larissa, Pneumonology Department

Larissa, , Greece

Countries

Greece

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851065&StudyName=Serotype%20Distribution%20of%20Chest%20X-ray%20Confirmed%20Pneumococcal%20Community%20Acquired%20Pneumonia%20%20in%20the%20Adult%20Population%20in%20Greece%2C%20Over%201%20Ye

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Other Identifiers

B1851065

Identifier Type: -

Identifier Source: org_study_id