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

4 décembre 2017 mis à jour par: 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

Aperçu de l'étude

Statut

Inconnue

Les conditions

Type d'étude

Observationnel

Inscription (Anticipé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

France
- - Nancy, France, 54000
    - Recrutement
    - Baux
    - Contact:
      
      Elisabeth Baux, MD
      
      Numéro de téléphone: +33 03 83 15 28 65
      
      E-mail: e.baux@chru-nancy.fr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number of dead patients Délai: 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)

Mesures de résultats secondaires

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Central Hospital, Nancy, France

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2017

Achèvement primaire (Réel)

20 octobre 2017

Achèvement de l'étude (Anticipé)

1 mars 2018

Dates d'inscription aux études

Première soumission

18 novembre 2017

Première soumission répondant aux critères de contrôle qualité

4 décembre 2017

Première publication (Réel)

11 décembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 décembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 décembre 2017

Dernière vérification

1 novembre 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

RNI2017/FLUVALENTINE-BAUX/YB

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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États-Unis

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