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

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

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
Pneumococcal Disease	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

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

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]
calendar year. [One year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

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