Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011.

NCT02884700 | Completed

• 1 other identifier: Grenobole University Hospital
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aimed at further describing the epidemiological, clinical, diagnostic and prognostic features in legionellosis cases admitted to Grenoble University Hospital during the 2006-2011period. The investigators also tested lower respiratory samples collected from these patients during their routine medical care, using a number of molecular tools allowing determination of the involved Legionella species, the bacterial load, and the presence of antibiotic resistant mutants. Our primary goal was to define biological markers that could predict severity and outcome of infection in legionellosis cases requiring hospitalization.

Conditions

Legionnaires' Disease

Keywords

Legionella; Legionnaires' disease; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (1)

• Legionella DNA load in lower respiratory tract samples

  Real-time polymerase chain reaction (qPCR) dosages in lower respiratory tract samples collected on a routine basis all over the hospitalization duration

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples

  through study completion, an average of 1 year

Study Arms (1)

Severe legionellosis cases

Patients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011.

Biological: Real-time PCR testing of lower respiratory tract samples

Interventions

Real-time PCR testing of lower respiratory tract samples BIOLOGICAL

qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis

Severe legionellosis cases

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97 years severe legionellosis requiring hospitalization

You may qualify if:

• age higher than 18 years
• proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
• severe case requiring hospitalization

You may not qualify if:

• age under 18 years
• pregnant women

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Biospecimen

Retention: SAMPLES WITH DNA

Lower respiratory tract samples collected on a routine basis for microbiological analyses

MeSH Terms

Conditions

Legionnaires' Disease; Disease

Condition Hierarchy (Ancestors)

Legionellosis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hélène Sabbah-Guillaume, Director

  Direction of Research and Medical Innovation (DRCI)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr. Max Maurin

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2014
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share