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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
General Hospital of Athens "Evangelismos" / Pneumonology Department
Athens, Attiki, Greece
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT01564771
Pfizer
Completed
Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.

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Descriptive Information
Brief TitleSerotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
Official TitleSerotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
Brief SummarySerotype 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 DescriptionFor 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Urine Samples
Sampling MethodNon-Probability Sample
Study PopulationAdults ?18 years of age with chest X-ray confirmed CAP
ConditionPneumococcal Disease
InterventionOther: Non Intervention
This Is A Non Interventional Study
Study Groups/CohortsGroup 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 StatusCompleted
Actual Enrollment
 (submitted: November 30, 2018)
293
Original Estimated Enrollment
 (submitted: March 27, 2012)
500
Actual Study Completion DateApril 2013
Actual Primary Completion DateApril 2013   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGreece
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01564771
Other Study ID NumbersB1851065
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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