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

Pneumococcal Disease Clinical Trial

— B1851065  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564771
• Other study ID #: B1851065
• Status: Completed
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections
• Pneumonia

Intervention

Other:
• Non Intervention
This Is A Non Interventional Study

Locations

Country	Name	City	State
Greece	General University Hospital of Alexandroupoli	Alexandroupoli
Greece	University Hospital of Alexandroupolis	Alexandroupoli	Evros
Greece	Diagnostic Therapeutic Center of Athens Ygeia	Athens
Greece	General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine	Athens
Greece	General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic	Athens
Greece	General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic	Athens
Greece	General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department	Athens
Greece	General Hospital of Athens "Evangelismos" / Pneumonology Department	Athens	Attiki
Greece	General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department	Athens
Greece	General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	calendar year.		One year
Secondary	Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.		One year
Secondary	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

External Links

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