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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275691
First Posted: January 12, 2006
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose
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 Phase
Cough Fever Phase 2 Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR

Further study details as provided by Mayo Clinic:

Enrollment: 867
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275691


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Franklin R. Cockerill, III, M.D. Mayo Clinic
  More Information

Responsible Party: Franklin R Cockerill, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275691     History of Changes
Other Study ID Numbers: 2354-02
First Submitted: January 10, 2006
First Posted: January 12, 2006
Last Update Posted: January 18, 2010
Last Verified: January 2010