Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
NCT01564771
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- 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)
- 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)
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Descriptive Information | ||||
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Brief Title | 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. | |||
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 | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Urine Samples | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Adults ?18 years of age with chest X-ray confirmed CAP | |||
Condition | Pneumococcal Disease | |||
Intervention | Other: Non Intervention
This Is A Non Interventional Study | |||
Study Groups/Cohorts | Group one
Adults ?18 years of age with chest X-ray confirmed CAP Intervention: Other: Non Intervention | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 293 | |||
Original Estimated Enrollment | 500 | |||
Actual Study Completion Date | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Greece | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01564771 | |||
Other Study ID Numbers | B1851065 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2018 |