Trial record 1 of 1 for:
NCT01086397
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia
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ClinicalTrials.gov Identifier: NCT01086397 |
Recruitment Status :
Completed
First Posted : March 15, 2010
Last Update Posted : March 15, 2012
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
Tracking Information | ||||
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First Submitted Date | March 11, 2010 | |||
First Posted Date | March 15, 2010 | |||
Last Update Posted Date | March 15, 2012 | |||
Study Start Date | February 2010 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. [ Time Frame: 6-12 months ] | |||
Original Primary Outcome Measures |
Using an investigational assay, to estimate the proportion of PCV13 serotype S pneumoniae among adults, 50 years of age and older presenting with chest x-ray confirmed CAP to selected US hospitals. [ Time Frame: 18 months ] | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia | |||
Official Title | Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP) | |||
Brief Summary | The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria Streptococcus pneumoniae (also called pneumococcus). | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: urine serum and potentially blood isolates
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Sampling Method | Non-Probability Sample | |||
Study Population | Adults 50 years and older presenting to Selected US Hospitals With Chest X-ray Confirmed Community-Acquired Pneumonia (CAP) | |||
Condition |
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Intervention | Procedure: Urine sample collection
All subjects have non-invasive urine sample collection performed
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Study Groups/Cohorts | 1
Intervention: Procedure: Urine sample collection
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
782 | |||
Original Estimated Enrollment |
1302 | |||
Actual Study Completion Date | October 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01086397 | |||
Other Study ID Numbers | 6115A1-4007 B1851032 |
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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 |
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PRS Account | Pfizer | |||
Verification Date | March 2012 |