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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564771
First received: March 26, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pneumococcal Disease
Other: Non Intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • calendar year. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine Samples


Enrollment: 320
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group one
Adults ≥18 years of age with chest X-ray confirmed CAP
Other: Non Intervention
This Is A Non Interventional Study

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564771

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564771     History of Changes
Other Study ID Numbers: B1851065
Study First Received: March 26, 2012
Last Updated: August 20, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Pfizer:
Pneumococcal serotypes
Community Acquired Pneumonia (CAP)

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 01, 2014