Clinical trial NCT01564771: Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
Official title: Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Keywords: Pneumococcal serotypes
Community Acquired Pneumonia (CAP)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ≥18 years of age with chest X-ray confirmed CAP

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.

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 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)

Primary outcomes:
measure: 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
timeFrame: One year
measure: calendar year.
timeFrame: One year
Secondary outcomes:
measure: Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.
timeFrame: One year
measure: 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.
timeFrame: One year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos" / Pneumonology Department
state: Attiki
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
city: Alexandroupoli
country: Greece
facility: General University Hospital of Alexandroupoli
city: Athens
country: Greece
facility: General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic
city: Athens
country: Greece
facility: Diagnostic Therapeutic Center of Athens Ygeia
city: Athens
country: Greece
facility: General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department
city: Athens
country: Greece
facility: General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic
city: Athens
country: Greece
facility: General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department
city: Athens
country: Greece
facility: Sotiria Hospital, Intensive Care Unit
city: Athnens
country: Greece
facility: General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med
city: Kavala
country: Greece
facility: General Hospital of Kavala/ A Pneumonological Clinic
city: Kavala
country: Greece
facility: General Hospital of Kavala/ b Pneumonological & Tubeculosis Department
city: Larissa
country: Greece
facility: University General Hospial of Larissa, Pneumonology Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: