Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452153
Status:
TERMINATED
Last Update Posted:
2015-07-29
First Post:
2007-03-26
Brief Title:
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Too much difficulties to includ patient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The validity of molecular techniques for the diagnosis of legionellosis is not known Although PCR can detect Legionella pneumophila responsible for 80 of legionellosis and other Legionella species this test is not recommended in standard guidelines to assess this diagnostic by contrast to culture of sputum serology and urine antigen The aim of this study is to evaluate Legionella PCR techniques performed directly onto the sputum aspirates for the routine diagnosis of pneumonia in adults patients admitted to hospital This study implicates 3 University hospitals Lyon Grenoble and Saint-Etienne in collaboration with the French reference center of legionellosis for a previous duration of one year In addition to the usual diagnostic tests that are performed when pneumonia is suspected real-time PCR will be added for the detection and differentiation of Legionella Hypothesizing the inclusion of 1000 pneumonia in this study the predictable number of newly-detected legionellosis will be approximately 60 to 70 cases According to a predefined algorithm cases of legionellosis will be classified as definite or probable Sensitivity and specificity of the real-time PCR will be calculated according to this classification This study is intended to validate real-time PCR as a tool for the rapid diagnosis of legionellosis allowing to optimize the antibiotic treatment of pneumonia PCR techniques can also contribute to the better detection and differentiation of Legionella sp infections that are not documented accurately by routine microbiologic tests
Detailed Description:
None
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