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

November 30, 2018 updated by: Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

293

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupoli, Greece, 68100
        • General University Hospital of Alexandroupoli
      • Athens, Greece, 11527
        • General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic
      • Athens, Greece, 11527
        • General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic
      • Athens, Greece, 15123
        • Diagnostic Therapeutic Center of Athens Ygeia
      • Athens, Greece, 15126
        • General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic
      • Athens, Greece, 15126
        • General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department
      • Athens, Greece, 15126
        • General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic
      • Athens, Greece, 15127
        • General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic
      • Athens, Greece, 15127
        • General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department
      • Athens, Greece, 15227
        • Sotiria Hospital, Intensive Care Unit
      • Athnens, Greece
        • General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med
      • Kavala, Greece, 65201
        • General Hospital of Kavala/ A Pneumonological Clinic
      • Kavala, Greece, 65201
        • General Hospital of Kavala/ b Pneumonological & Tubeculosis Department
      • Larissa, Greece, 41 110
        • University General Hospial of Larissa, Pneumonology Department
    • Attiki
      • Athens, Attiki, Greece
        • General Hospital of Athens "Evangelismos" / Pneumonology Department
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • University Hospital of Alexandroupolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group one
Adults ≥18 years of age with chest X-ray confirmed CAP
Other: Non Intervention
This Is A Non Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year
calendar year.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.
Time Frame: One year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1851065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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