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

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

Study Overview

• Status: Unknown
• Conditions: Influenza; Staphylococcus Aureus Pneumonia; PV Leukocidin

• Study Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Baux
    • Contact: Elisabeth Baux, MD; Phone Number: +33 03 83 15 28 65; Email: e.baux@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of dead patients	All cause of mortality	During Length of stay in intensive care unit (an average of 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data relating to age	age	Baseline
Demographic data relating to sex	sex	Baseline
Respiratory failure	PaO2/iFO2 value	Baseline
Demographic data relating to immunosuppression	Amount of polynuclear neutrophils (G/L)	Baseline
risk factors for methicillin-resistant Staphylococcus aureus	hospitalization	Baseline
risk factors for methicillin-resistant Staphylococcus aureus	dialysis	Baseline
risk factors for methicillin-resistant Staphylococcus aureus	surgery	Baseline
risk factors for methicillin-resistant Staphylococcus aureus	presence of percutaneous or long-term catheter	Baseline
Clinical data relating to pre-admission antibiotics	type of antibiotic prescribed	Baseline
Clinical data in the initial phase relating to SAPS 2 score	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	Sequential Organ Failure Assessment (SOFA)	Baseline
Clinical data in the initial phase relating to neutropenia	neutropenia	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to neutropenia	thrombocytopenia	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to metabolic acidosis	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	oxygen dependence	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to hyperthermia	hyperthermia	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to chills	chills	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to headhache	headache	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to productive cough	productive cough	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase relating to dyspnoea	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	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	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	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	pleural effusion	During Length of stay in intensive care unit (an average of 2 weeks)
Clinical data in the initial phase	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	renal failure according to KDIGO classification	During Length of stay in intensive care unit (an average of 2 weeks)
Prognostic factors for this pathology	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	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	Bacteriological, Parasitological, Virological	During Length of stay in intensive care unit (an average of 2 weeks)
Probabilistic antibiotherapy	Collection of probabilistic antibiotherapy	During Length of stay in intensive care unit (an average of 2 weeks)
Probabilistic antibiotherapy	Duration of probabilistic antibiotherapy	During Length of stay in intensive care unit (an average of 2 weeks)
Prescribed antibiotic therapy	Collection of Prescribed antibiotic therapy	During Length of stay in intensive care unit (an average of 2 weeks)
Prescribed antibiotic therapy	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	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	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	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	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	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	Mortality caused by serious inflenza infections	During Length of stay in intensive care unit (an average of 2 weeks)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 20, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: November 18, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Pneumonia; influenza; ICU; Staphylococcus Aureus; PV leukocidin
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Orthomyxoviridae Infections; Pneumonia; Influenza, Human; Pneumonia, Bacterial; Staphylococcal Infections; Pneumonia, Staphylococcal
• Other Study ID Numbers: RNI2017/FLUVALENTINE-BAUX/YB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No