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Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year. (B1851065)

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ClinicalTrials.gov Identifier: NCT01564771
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date March 26, 2012
First Posted Date March 28, 2012
Last Update Posted Date December 3, 2018
Study Start Date January 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2014)
  • 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 [ Time Frame: One year ]
  • calendar year. [ Time Frame: One year ]
Original Primary Outcome Measures
 (submitted: March 27, 2012)
The frequency of serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, 19A in the samples collected from chest-X-ray confirmed pneumococcal pneumonia (CAP) adult patients [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT01564771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 27, 2012)
  • Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients. [ Time Frame: 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. [ Time Frame: One year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
 (submitted: November 30, 2018)
293
Original Estimated Enrollment
 (submitted: March 27, 2012)
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:

  • 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
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018