Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
4. desember 2017 oppdatert 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
Studieoversikt
Status
Ukjent
Studietype
Observasjonsmessig
Registrering (Forventet)
35
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Nancy, Frankrike, 54000
- Rekruttering
- Baux
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Ta kontakt med:
- Elisabeth Baux, MD
- Telefonnummer: +33 03 83 15 28 65
- E-post: e.baux@chru-nancy.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of dead patients
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Demographic data relating to age
Tidsramme: Baseline
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age
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Baseline
|
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Demographic data relating to sex
Tidsramme: Baseline
|
sex
|
Baseline
|
|
Respiratory failure
Tidsramme: Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
Tidsramme: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Tidsramme: Baseline
|
hospitalization
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Tidsramme: Baseline
|
dialysis
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Tidsramme: Baseline
|
surgery
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Tidsramme: Baseline
|
presence of percutaneous or long-term catheter
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Baseline
|
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Clinical data relating to pre-admission antibiotics
Tidsramme: Baseline
|
type of antibiotic prescribed
|
Baseline
|
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Clinical data in the initial phase relating to SAPS 2 score
Tidsramme: 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
Tidsramme: Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
Tidsramme: 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
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
metabolic acidosis
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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 oxygen dependence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
headache
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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 productive cough
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
hemoptysis
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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 uni - or multi - lobar infiltration on chest X - ray or CT scan
Tidsramme: 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
Tidsramme: 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)
|
|
Clinical data in the initial phase
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Tidsramme: During Length of stay in intensive care unit (an average of 2 weeks)
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
|
Probabilistic antibiotherapy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2017
Primær fullføring (Faktiske)
20. oktober 2017
Studiet fullført (Forventet)
1. mars 2018
Datoer for studieregistrering
Først innsendt
18. november 2017
Først innsendt som oppfylte QC-kriteriene
4. desember 2017
Først lagt ut (Faktiske)
11. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. desember 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungesykdommer
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Gram-positive bakterielle infeksjoner
- Orthomyxoviridae-infeksjoner
- Lungebetennelse
- Influensa, menneske
- Lungebetennelse, bakteriell
- Stafylokokkinfeksjoner
- Lungebetennelse, stafylokokker
Andre studie-ID-numre
- RNI2017/FLUVALENTINE-BAUX/YB
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