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
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Franklin R Cockerill, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275691     History of Changes
Other Study ID Numbers: 2354-02
Study First Received: January 10, 2006
Last Updated: January 15, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 22, 2014