Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
4 dicembre 2017 aggiornato da: Central Hospital, Nancy, France
Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies.
The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus
Panoramica dello studio
Stato
Sconosciuto
Tipo di studio
Osservativo
Iscrizione (Anticipato)
35
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Nancy, Francia, 54000
- Reclutamento
- Baux
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Contatto:
- Elisabeth Baux, MD
- Numero di telefono: +33 03 83 15 28 65
- Email: e.baux@chru-nancy.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients hospitalized in intensive care units for the management of influenza pneumonia infected with Panton-Valentine Leukocidin Positive Staphylococcus aureus over a retrospective period from 2009 to winter 2016-2017.
Descrizione
Inclusion Criteria:
- Patient treated for post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus in intensive care unit
Exclusion Criteria:
- Minor patient
- Patient under protective measurement
- Absence of bacteriological and / or virological documentation
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of dead patients
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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All cause of mortality
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During Length of stay in intensive care unit (an average of 2 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Demographic data relating to age
Lasso di tempo: Baseline
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age
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Baseline
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Demographic data relating to sex
Lasso di tempo: Baseline
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sex
|
Baseline
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Respiratory failure
Lasso di tempo: Baseline
|
PaO2/iFO2 value
|
Baseline
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Demographic data relating to immunosuppression
Lasso di tempo: Baseline
|
Amount of polynuclear neutrophils (G/L)
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Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Lasso di tempo: Baseline
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hospitalization
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Lasso di tempo: Baseline
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dialysis
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Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Lasso di tempo: Baseline
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surgery
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Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Lasso di tempo: Baseline
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presence of percutaneous or long-term catheter
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Baseline
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Clinical data relating to pre-admission antibiotics
Lasso di tempo: Baseline
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type of antibiotic prescribed
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Baseline
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Clinical data in the initial phase relating to SAPS 2 score
Lasso di tempo: Baseline
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Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
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Baseline
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Clinical data in the initial phase relating to SOFA admission
Lasso di tempo: Baseline
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Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
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Clinical data in the initial phase relating to neutropenia
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
neutropenia
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Clinical data in the initial phase relating to neutropenia
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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thrombocytopenia
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to metabolic acidosis
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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metabolic acidosis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to oxygen dependence
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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oxygen dependence
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to hyperthermia
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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hyperthermia
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to chills
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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chills
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to headhache
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
headache
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
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Clinical data in the initial phase relating to productive cough
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
productive cough
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Clinical data in the initial phase relating to dyspnoea
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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dyspnoea
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During Length of stay in intensive care unit (an average of 2 weeks)
|
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Clinical data in the initial phase relating to acute respiratory failure
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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acute respiratory failure
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During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hemoptysis
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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hemoptysis
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During Length of stay in intensive care unit (an average of 2 weeks)
|
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Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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uni - or multi - lobar infiltration on chest X - ray or CT scan
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to pleural effusion
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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pleural effusion
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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necrotizing pneumonitis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to renal failure
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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renal failure according to KDIGO classification
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During Length of stay in intensive care unit (an average of 2 weeks)
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Prognostic factors for this pathology
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Time to diagnosis of influenza infection and Panton-Valentine Leukocidin Positive Staphylococcus aureus Haemoptysis, leukopenia, thrombocytopenia, acute respiratory distress syndrome (ARDS), PaO2 / Fi02, inotropic support
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During Length of stay in intensive care unit (an average of 2 weeks)
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Complications
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Complications related to Septic shock ARDS: according to Berlin 2009 classification Extra corporeal vein-venous or veino-arterial oxygenation membrane (ECMO VV or ECMO VA) Ischemic limb Pneumothorax Acute renal failure according to Kdigo classification Disseminated intravascular coagulation (DIC) (2) Cardiogenic shock / cardiogenic pulmonary acute edema Multi visceral failure syndrome (3) Use of surgery: abscess drainage, lobectomy, amputation, laparotomy and colonic resection ...
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During Length of stay in intensive care unit (an average of 2 weeks)
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|
Collection of infectious samples
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Bacteriological, Parasitological, Virological
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
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Probabilistic antibiotherapy
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Probabilistic antibiotherapy
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prescribed antibiotic therapy
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of Prescribed antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prescribed antibiotic therapy
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration for the appropriate anti-toxin treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Collection of the date of introduction of adapted antibiotic therapy
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of the date of introduction of adapted antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type A
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type A
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type B
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type B
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Dosage of antiviral treatment
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Dosage of antiviral treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Number of serious influenza infections per year and per center with early and late deaths
Lasso di tempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Mortality caused by serious inflenza infections
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2017
Completamento primario (Effettivo)
20 ottobre 2017
Completamento dello studio (Anticipato)
1 marzo 2018
Date di iscrizione allo studio
Primo inviato
18 novembre 2017
Primo inviato che soddisfa i criteri di controllo qualità
4 dicembre 2017
Primo Inserito (Effettivo)
11 dicembre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 dicembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 dicembre 2017
Ultimo verificato
1 novembre 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Malattie polmonari
- Infezioni batteriche
- Infezioni batteriche e micosi
- Infezioni batteriche Gram-positive
- Infezioni da Orthomyxoviridae
- Polmonite
- Influenza, umana
- Polmonite, batterica
- Infezioni da stafilococco
- Polmonite, stafilococco
Altri numeri di identificazione dello studio
- RNI2017/FLUVALENTINE-BAUX/YB
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .