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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01564771
Collaborator
(none)
293
21
27
14
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non Intervention

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 Design

Study Type:
Observational
Actual Enrollment :
293 participants
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.
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Group one

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

Other: Non Intervention
This Is A Non Interventional Study

Outcome Measures

Primary Outcome Measures

  1. 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 [One year]

  2. calendar year. [One year]

Secondary Outcome Measures

  1. Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients. [One year]

  2. 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. [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 General Hospital of Athens "Evangelismos" / Pneumonology Department Athens Attiki Greece
2 University Hospital of Alexandroupolis Alexandroupoli Evros Greece 68100
3 General University Hospital of Alexandroupoli Alexandroupoli Greece 68100
4 General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine Athens Greece 11527
5 General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic Athens Greece 11527
6 General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic Athens Greece 11527
7 General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic Athens Greece 11527
8 General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic Athens Greece 11527
9 General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic Athens Greece 11527
10 General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic Athens Greece 11527
11 Diagnostic Therapeutic Center of Athens Ygeia Athens Greece 15123
12 General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic Athens Greece 15126
13 General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department Athens Greece 15126
14 General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic Athens Greece 15126
15 General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic Athens Greece 15127
16 General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department Athens Greece 15127
17 Sotiria Hospital, Intensive Care Unit Athens Greece 15227
18 General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med Athnens Greece
19 General Hospital of Kavala/ A Pneumonological Clinic Kavala Greece 65201
20 General Hospital of Kavala/ b Pneumonological & Tubeculosis Department Kavala Greece 65201
21 University General Hospial of Larissa, Pneumonology Department Larissa Greece 41 110

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01564771
Other Study ID Numbers:
  • B1851065
First Posted:
Mar 28, 2012
Last Update Posted:
Dec 3, 2018
Last Verified:
Nov 1, 2018
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2018