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

4 december 2017 bijgewerkt door: 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

Studie Overzicht

Toestand

Onbekend

Conditie

Studietype

Observationeel

Inschrijving (Verwacht)

35

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of dead patients
Tijdsspanne: 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)

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Central Hospital, Nancy, France

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2017

Primaire voltooiing (Werkelijk)

20 oktober 2017

Studie voltooiing (Verwacht)

1 maart 2018

Studieregistratiedata

Eerst ingediend

18 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

4 december 2017

Eerst geplaatst (Werkelijk)

11 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 december 2017

Laatste update ingediend die voldeed aan QC-criteria

4 december 2017

Laatst geverifieerd

1 november 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RNI2017/FLUVALENTINE-BAUX/YB

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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