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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275691
First received: January 10, 2006
Last updated: January 15, 2010
Last verified: January 2010

January 10, 2006
January 15, 2010
October 2005
June 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00275691 on ClinicalTrials.gov Archive Site
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Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR

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.

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.

Observational
Time Perspective: Prospective
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Probability Sample

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

  • Cough
  • Fever
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
867
June 2008
June 2008   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275691
2354-02
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Franklin R Cockerill, MD, Mayo Clinic
Mayo Clinic
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Principal Investigator: Franklin R. Cockerill, III, M.D. Mayo Clinic
Mayo Clinic
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP