Evaluation of Legionella PCR Techniques for the Routine Diagnosis of Legionellosis

NCT ID: NCT00452153

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Legionellosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Characterization Legionnella

Characterization Legionnella by polymerase chain reaction (PCR)

Group Type EXPERIMENTAL

Characterization Legionnella

Intervention Type PROCEDURE

* Characterisation Legionnella by polymerase chain reaction (PCR)
* Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

Interventions

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Characterization Legionnella

* Characterisation Legionnella by polymerase chain reaction (PCR)
* Characterization strain of Legionnella by sequencing the 23S-5S ribosomal intergenic spacer region

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Patient affiliated to social insurance
* Community acquired or nosocomial pneumonia

Exclusion Criteria

* No sputum aspirate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Berthelot, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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HMU CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Infectious Disease unit CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Pneumology unit CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Reanimation unit - Hopital Bellevue - CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Reanimation unit - Hôpital NORD - CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Urgency unit CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16061143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15010573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8735131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12843082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15872220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3106925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7620012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12574296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16198139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11427579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12958219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12614979 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12354888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16000443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12415469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11525995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12168744 (View on PubMed)

Other Identifiers

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0601072

Identifier Type: -

Identifier Source: org_study_id

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