Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
4. Dezember 2017 aktualisiert von: 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
Studienübersicht
Status
Unbekannt
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
35
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Nancy, Frankreich, 54000
- Rekrutierung
- Baux
-
Kontakt:
- Elisabeth Baux, MD
- Telefonnummer: +33 03 83 15 28 65
- E-Mail: e.baux@chru-nancy.fr
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of dead patients
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Demographic data relating to age
Zeitfenster: Baseline
|
age
|
Baseline
|
|
Demographic data relating to sex
Zeitfenster: Baseline
|
sex
|
Baseline
|
|
Respiratory failure
Zeitfenster: Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
Zeitfenster: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Zeitfenster: Baseline
|
hospitalization
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Zeitfenster: Baseline
|
dialysis
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Zeitfenster: Baseline
|
surgery
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Zeitfenster: Baseline
|
presence of percutaneous or long-term catheter
|
Baseline
|
|
Clinical data relating to pre-admission antibiotics
Zeitfenster: Baseline
|
type of antibiotic prescribed
|
Baseline
|
|
Clinical data in the initial phase relating to SAPS 2 score
Zeitfenster: 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
Zeitfenster: Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During Length of stay in intensive care unit (an average of 2 weeks)
|
hyperthermia
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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 chills
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2017
Primärer Abschluss (Tatsächlich)
20. Oktober 2017
Studienabschluss (Voraussichtlich)
1. März 2018
Studienanmeldedaten
Zuerst eingereicht
18. November 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Dezember 2017
Zuerst gepostet (Tatsächlich)
11. Dezember 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Dezember 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Dezember 2017
Zuletzt verifiziert
1. November 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Infektionen der Atemwege
- Erkrankungen der Atemwege
- Lungenkrankheit
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Grampositive bakterielle Infektionen
- Orthomyxoviridae-Infektionen
- Lungenentzündung
- Grippe, Mensch
- Lungenentzündung, bakteriell
- Staphylokokken-Infektionen
- Lungenentzündung, Staphylokokken
Andere Studien-ID-Nummern
- RNI2017/FLUVALENTINE-BAUX/YB
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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