Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275691
Status:
COMPLETED
Last Update Posted:
2010-01-18
First Post:
2006-01-10
Brief Title:
Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluation of Respiratory Specimens for Bacterial and Viral Pathogens by Real-Time PCR
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Community acquired pneumoniaCAP 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
Detailed Description:
Excess patient specimens normally collected for routine microbiologic testing for CAP and in some cases additional specimens ieblood 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 Mpneumoniae 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None