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Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00275691
Collaborator
(none)
867
Enrollment
1
Location
32
Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Community acquired pneumonia(CAP) is a common cause of morbidity and mortality. The diagnosis of CAP from the microbiology perspective has been challenging. Recent reports suggest the utility of real-time PCR for rapid and accurate diagnoses of these pathogens. Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Excess patient specimens normally collected for routine microbiologic testing for CAP and in some cases additional specimens (i.e.,blood, urine, throat swab) will be evaluated using real-time PCR tests developed in our laboratory. Specimens will be performed on patients suspect for CAP. Test will be directed at variety of pathogens including but not limited to M.pneumoniae, C. pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, B. pertussis, influenza viruses, adenovirus, and metapneumovirus. The ultimate goal is to have a panel of highly accurate and rapid (same day) tests that can be orderable and performed in short period time for CAP cases.

    Real-Time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction of nucleic acid. Real-time PCR tests, using the LightCycler instrument, will be performed on excess or additional specimens after extraction nucleic acid. These tests will include the organisms listed above. As nucleic acid extracts will be archived, other pathogens can be tested in the future should we develop additional real-time PCR tests. All results obtained by real-time PCR will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional PCR testing and or medical history review will be conducted.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    867 participants
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
    Study Start Date :
    Oct 1, 2005
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      Greater than 18 years of age. Cough present greater than one day and a history of fever and chills or documented fever in the Emergency Department

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Mayo Clinic Rochester Minnesota United States 55905

      Sponsors and Collaborators

      • Mayo Clinic

      Investigators

      • Principal Investigator: Franklin R. Cockerill, III, M.D., Mayo Clinic

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00275691
      Other Study ID Numbers:
      • 2354-02
      First Posted:
      Jan 12, 2006
      Last Update Posted:
      Jan 18, 2010
      Last Verified:
      Jan 1, 2010

      Study Results

      No Results Posted as of Jan 18, 2010