- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02884700
Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011. (LEGIOGRE)
Molecular Epidemiology of Legionellosis in Grenoble Region
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Legionella DNA load in lower respiratory tract samples
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Hélène Sabbah-Guillaume, Director, Direction of Research and Medical Innovation (DRCI)
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Grenobole University Hospital
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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