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

4 december 2017 uppdaterad av: 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

Studieöversikt

Status

Okänd

Betingelser

Studietyp

Observationell

Inskrivning (Förväntat)

35

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of dead patients
Tidsram: 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)

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

Central Hospital, Nancy, France

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2017

Primärt slutförande (Faktisk)

20 oktober 2017

Avslutad studie (Förväntat)

1 mars 2018

Studieregistreringsdatum

Först inskickad

18 november 2017

Först inskickad som uppfyllde QC-kriterierna

4 december 2017

Första postat (Faktisk)

11 december 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 december 2017

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RNI2017/FLUVALENTINE-BAUX/YB

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