- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452153
Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis
July 28, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-etienne, France, 42055
- HMU CHU Saint-Etienne
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Saint-etienne, France, 42055
- Infectious Disease unit CHU de Saint-Etienne
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Saint-etienne, France, 42055
- Pneumology unit CHU de Saint-Etienne
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Saint-etienne, France, 42055
- Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne
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Saint-etienne, France, 42055
- Reanimation unit - Hôpital NORD - CHU de Saint-Etienne
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Saint-etienne, France, 42055
- Urgency unit CHU Saint-Etienne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent
- Patient affiliated to social insurance
- Community acquired or nosocomial pneumonia
Exclusion Criteria:
- No sputum aspirate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Characterization Legionnella
Characterization Legionnella by polymerase chain reaction (PCR)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Definite or probable legionellosis
Time Frame: Inclusion and J30
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Inclusion and J30
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Definite legionellosis
Time Frame: Inclusion and J30
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Inclusion and J30
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Probable legionellosis
Time Frame: Inclusion and J30
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Inclusion and J30
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Possible legionellosis
Time Frame: Inclusion and J30
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Inclusion and J30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Philippe Berthelot, PU-PH, CHU-Saint-Etienne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Squier CL, Stout JE, Krsytofiak S, McMahon J, Wagener MM, Dixon B, Yu VL. A proactive approach to prevention of health care-acquired Legionnaires' disease: the Allegheny County (Pittsburgh) experience. Am J Infect Control. 2005 Aug;33(6):360-7. doi: 10.1016/j.ajic.2005.01.012.
- Decludt B, Campese C, Lacoste M, Che D, Jarraud S, Etienne J. Clusters of travel associated legionnaires' disease in France, September 2001- August 2003. Euro Surveill. 2004 Feb;9(2):12-3. doi: 10.2807/esm.09.02.00446-en.
- Grattard F, Berthelot P, Reyrolle M, Ros A, Etienne J, Pozzetto B. Molecular typing of nosocomial strains of Legionella pneumophila by arbitrarily primed PCR. J Clin Microbiol. 1996 Jun;34(6):1595-8. doi: 10.1128/jcm.34.6.1595-1598.1996.
- Aurell H, Etienne J, Forey F, Reyrolle M, Girardo P, Farge P, Decludt B, Campese C, Vandenesch F, Jarraud S. Legionella pneumophila serogroup 1 strain Paris: endemic distribution throughout France. J Clin Microbiol. 2003 Jul;41(7):3320-2. doi: 10.1128/JCM.41.7.3320-3322.2003.
- Gaia V, Fry NK, Afshar B, Luck PC, Meugnier H, Etienne J, Peduzzi R, Harrison TG. Consensus sequence-based scheme for epidemiological typing of clinical and environmental isolates of Legionella pneumophila. J Clin Microbiol. 2005 May;43(5):2047-52. doi: 10.1128/JCM.43.5.2047-2052.2005.
- Wang EE, Manson B, Corey M, Bernard K, Prober CG. False positivity of Legionella serology in patients with cystic fibrosis. Pediatr Infect Dis J. 1987 Mar;6(3):256-9. doi: 10.1097/00006454-198703000-00009.
- Plouffe JF, File TM Jr, Breiman RF, Hackman BA, Salstrom SJ, Marston BJ, Fields BS. Reevaluation of the definition of Legionnaires' disease: use of the urinary antigen assay. Community Based Pneumonia Incidence Study Group. Clin Infect Dis. 1995 May;20(5):1286-91. doi: 10.1093/clinids/20.5.1286.
- Helbig JH, Uldum SA, Bernander S, Luck PC, Wewalka G, Abraham B, Gaia V, Harrison TG. Clinical utility of urinary antigen detection for diagnosis of community-acquired, travel-associated, and nosocomial legionnaires' disease. J Clin Microbiol. 2003 Feb;41(2):838-40. doi: 10.1128/JCM.41.2.838-840.2003.
- Grattard F, Ginevra C, Riffard S, Ros A, Jarraud S, Etienne J, Pozzetto B. Analysis of the genetic diversity of Legionella by sequencing the 23S-5S ribosomal intergenic spacer region: from phylogeny to direct identification of isolates at the species level from clinical specimens. Microbes Infect. 2006 Jan;8(1):73-83. doi: 10.1016/j.micinf.2005.05.022. Epub 2005 Aug 8.
- Hayden RT, Uhl JR, Qian X, Hopkins MK, Aubry MC, Limper AH, Lloyd RV, Cockerill FR. Direct detection of Legionella species from bronchoalveolar lavage and open lung biopsy specimens: comparison of LightCycler PCR, in situ hybridization, direct fluorescence antigen detection, and culture. J Clin Microbiol. 2001 Jul;39(7):2618-26. doi: 10.1128/JCM.39.7.2618-2626.2001.
- Templeton KE, Scheltinga SA, Sillekens P, Crielaard JW, van Dam AP, Goossens H, Claas EC. Development and clinical evaluation of an internally controlled, single-tube multiplex real-time PCR assay for detection of Legionella pneumophila and other Legionella species. J Clin Microbiol. 2003 Sep;41(9):4016-21. doi: 10.1128/JCM.41.9.4016-4021.2003.
- Welti M, Jaton K, Altwegg M, Sahli R, Wenger A, Bille J. Development of a multiplex real-time quantitative PCR assay to detect Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae in respiratory tract secretions. Diagn Microbiol Infect Dis. 2003 Feb;45(2):85-95. doi: 10.1016/s0732-8893(02)00484-4.
- Reischl U, Linde HJ, Lehn N, Landt O, Barratt K, Wellinghausen N. Direct detection and differentiation of Legionella spp. and Legionella pneumophila in clinical specimens by dual-color real-time PCR and melting curve analysis. J Clin Microbiol. 2002 Oct;40(10):3814-7. doi: 10.1128/JCM.40.10.3814-3817.2002.
- Ginevra C, Barranger C, Ros A, Mory O, Stephan JL, Freymuth F, Joannes M, Pozzetto B, Grattard F. Development and evaluation of Chlamylege, a new commercial test allowing simultaneous detection and identification of Legionella, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in clinical respiratory specimens by multiplex PCR. J Clin Microbiol. 2005 Jul;43(7):3247-54. doi: 10.1128/JCM.43.7.3247-3254.2005.
- Helbig JH, Bernander S, Castellani Pastoris M, Etienne J, Gaia V, Lauwers S, Lindsay D, Luck PC, Marques T, Mentula S, Peeters MF, Pelaz C, Struelens M, Uldum SA, Wewalka G, Harrison TG. Pan-European study on culture-proven Legionnaires' disease: distribution of Legionella pneumophila serogroups and monoclonal subgroups. Eur J Clin Microbiol Infect Dis. 2002 Oct;21(10):710-6. doi: 10.1007/s10096-002-0820-3. Epub 2002 Oct 18.
- Wellinghausen N, Frost C, Marre R. Detection of legionellae in hospital water samples by quantitative real-time LightCycler PCR. Appl Environ Microbiol. 2001 Sep;67(9):3985-93. doi: 10.1128/AEM.67.9.3985-3993.2001.
- Woodhead M. Community-acquired pneumonia in Europe: causative pathogens and resistance patterns. Eur Respir J Suppl. 2002 Jul;36:20s-27s. doi: 10.1183/09031936.02.00702002.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 26, 2007
First Posted (ESTIMATE)
March 27, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0601072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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