- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02884700
Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011. (LEGIOGRE)
Molecular Epidemiology of Legionellosis in Grenoble Region
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients admitted to Grenoble University Hospital between 2006 and 2011 for severe legionellosis were retrospectively included in the study.
Clinical, epidemiological, diagnostic and prognostic data of these patients were recorded retrospectively.
Lower respiratory samples collected from these patients on a routine basis for microbiological analysis, especially Legionella culture, were tested using traditional microbiological methods. The remaining part of these samples was stored at -80°C fur further molecular analyses.
The molecular tools developed by our bacteriology laboratory included the following: a real-time polymerase chain reaction (qPCR) test allowing detection and differentiation of L. pneumophila and other Legionella species; a qPCR test allowing determination of the Legionella DNA load in lower respiratory samples; a qPCR allowing detection of gyrA (the gene encoding subunit A of DNA gyrase) mutations that the investigators previously determined to be correlated with fluoroquinolones resistance in L. pneumophila; a high-throughput sequencing approach allowing confirmation of gyrA mutations and determination of the percentage of mutated alleles.
The microbiological data, especially those obtained with the developped molecular tools, were tentatively correlated with the severity and outcome of infection in our patients' cohort.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- age higher than 18 years
- proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
- severe case requiring hospitalization
Exclusion Criteria:
- age under 18 years
- pregnant women
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Severe legionellosis cases
Patients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011.
|
qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Legionella DNA load in lower respiratory tract samples
Tidsramme: through study completion, an average of 1 year
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples
Tidsramme: through study completion, an average of 1 year
|
Real-time polymerase chain reaction (qPCR) and high-throughput DNA sequencing testing of lower respiratory tract samples collected on a routine basis all over the hospitalization duration
|
through study completion, an average of 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Hélène Sabbah-Guillaume, Director, Direction of Research and Medical Innovation (DRCI)
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Grenobole University Hospital
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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