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Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)

4. prosince 2017 aktualizováno: 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

Přehled studie

Postavení

Neznámý

Podmínky

Typ studie

Pozorovací

Zápis (Očekávaný)

35

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Nancy, Francie, 54000
        • Nábor
        • Baux
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of dead patients
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
All cause of mortality
During Length of stay in intensive care unit (an average of 2 weeks)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Demographic data relating to age
Časové okno: Baseline
age
Baseline
Demographic data relating to sex
Časové okno: Baseline
sex
Baseline
Respiratory failure
Časové okno: Baseline
PaO2/iFO2 value
Baseline
Demographic data relating to immunosuppression
Časové okno: Baseline
Amount of polynuclear neutrophils (G/L)
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Časové okno: Baseline
hospitalization
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Časové okno: Baseline
dialysis
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Časové okno: Baseline
surgery
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Časové okno: Baseline
presence of percutaneous or long-term catheter
Baseline
Clinical data relating to pre-admission antibiotics
Časové okno: Baseline
type of antibiotic prescribed
Baseline
Clinical data in the initial phase relating to SAPS 2 score
Časové okno: Baseline
Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
Baseline
Clinical data in the initial phase relating to SOFA admission
Časové okno: Baseline
Sequential Organ Failure Assessment (SOFA)
Baseline
Clinical data in the initial phase relating to neutropenia
Časové okno: 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)
Clinical data in the initial phase relating to neutropenia
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
thrombocytopenia
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to metabolic acidosis
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
metabolic acidosis
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to oxygen dependence
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
oxygen dependence
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to hyperthermia
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
hyperthermia
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to chills
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
chills
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to headhache
Časové okno: 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)
Clinical data in the initial phase relating to productive cough
Časové okno: 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)
Clinical data in the initial phase relating to dyspnoea
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
dyspnoea
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to acute respiratory failure
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
acute respiratory failure
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to hemoptysis
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
hemoptysis
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
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)
Clinical data in the initial phase relating to pleural effusion
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
pleural effusion
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
necrotizing pneumonitis
During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to renal failure
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
renal failure according to KDIGO classification
During Length of stay in intensive care unit (an average of 2 weeks)
Prognostic factors for this pathology
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
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
During Length of stay in intensive care unit (an average of 2 weeks)
Complications
Časové okno: 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 ...
During Length of stay in intensive care unit (an average of 2 weeks)
Collection of infectious samples
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
Bacteriological, Parasitological, Virological
During Length of stay in intensive care unit (an average of 2 weeks)
Probabilistic antibiotherapy
Časové okno: 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)
Probabilistic antibiotherapy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
During Length of stay in intensive care unit (an average of 2 weeks)
Dosage of antiviral treatment
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
Dosage of antiviral treatment
During Length of stay in intensive care unit (an average of 2 weeks)
Number of serious influenza infections per year and per center with early and late deaths
Časové okno: During Length of stay in intensive care unit (an average of 2 weeks)
Mortality caused by serious inflenza infections
During Length of stay in intensive care unit (an average of 2 weeks)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Central Hospital, Nancy, France

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. října 2017

Primární dokončení (Aktuální)

20. října 2017

Dokončení studie (Očekávaný)

1. března 2018

Termíny zápisu do studia

První předloženo

18. listopadu 2017

První předloženo, které splnilo kritéria kontroly kvality

4. prosince 2017

První zveřejněno (Aktuální)

11. prosince 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. prosince 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. prosince 2017

Naposledy ověřeno

1. listopadu 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RNI2017/FLUVALENTINE-BAUX/YB

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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