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

2017. december 4. frissítette: 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

A tanulmány áttekintése

Állapot

Ismeretlen

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Várható)

35

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of dead patients
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Demographic data relating to age
Időkeret: Baseline
age
Baseline
Demographic data relating to sex
Időkeret: Baseline
sex
Baseline
Respiratory failure
Időkeret: Baseline
PaO2/iFO2 value
Baseline
Demographic data relating to immunosuppression
Időkeret: Baseline
Amount of polynuclear neutrophils (G/L)
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Időkeret: Baseline
hospitalization
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Időkeret: Baseline
dialysis
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Időkeret: Baseline
surgery
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Időkeret: Baseline
presence of percutaneous or long-term catheter
Baseline
Clinical data relating to pre-admission antibiotics
Időkeret: Baseline
type of antibiotic prescribed
Baseline
Clinical data in the initial phase relating to SAPS 2 score
Időkeret: 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
Időkeret: Baseline
Sequential Organ Failure Assessment (SOFA)
Baseline
Clinical data in the initial phase relating to neutropenia
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Central Hospital, Nancy, France

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2017. október 1.

Elsődleges befejezés (Tényleges)

2017. október 20.

A tanulmány befejezése (Várható)

2018. március 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2017. november 18.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2017. december 4.

Első közzététel (Tényleges)

2017. december 11.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2017. december 11.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. december 4.

Utolsó ellenőrzés

2017. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • RNI2017/FLUVALENTINE-BAUX/YB

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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