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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275691
• Other study ID #: 2354-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2006
• Last updated: January 15, 2010
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cough
• Fever

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,