Clinical Trial: Panton Valentine Leucocidin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

Brief Summary:

Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet, 2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet, 2002;359:753-9). Ten year after the first description of this disease and a number of controversies in the scientific literature, the question arise as to whether PVL remains an independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain unanswered yet; these are:

  • (i) which factors, including treatment regimen, are associated with favourable outcome?,
  • (ii) what is the susceptibility toward antibiotics of strains associated with this disease ?
  • (iii) is there any genetic susceptibility of the host to explain both the rarity, and the explosive presentation of the disease ? To address the above questions a prospective observational study at the nationwide level will be set up. All French hospitals will be invited to describe the clinical features of all new cases of S. aureus community-acquired pneumonia with severity criteria, regardless PVL production. The study will include an investigation of a possible innate immune dysfunction in collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté Necker, Paris). Hence, in addition to collecting clinical and biological data from all pneumonia cases as well as all strains of S. aureus isolated, the patients with PVL-positive pneumonia will be sa

    Detailed Summary:
    Sponsor: Hospices Civils de Lyon

    Current Primary Outcome: The survival of the patients according to the character PVL+ or PVL- of the isolated Staphylococcus aureus strains [ Time Frame: After hospitalisation, an average of 21 days ]

    Percentage of alive patients after the length of stay in hospitalisation


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Gravity Scores : Composite measure between the IGS2 and SOFA scores for an adult and between PIM2 and PLEOD scores for a child [ Time Frame: At admission at Reanimation Unit or ICU, at 24 h after admission and 7 days after admission ]
    • length of stay in Reanimation and ICU [ Time Frame: number of days in Reanimation and ICU ]
      After hospitalisation, an average of 21 days
    • length of stay in hospitalization [ Time Frame: After hospitalisation, an average of 21 days ]
    • Number of participants with presence of a genetic predisposition of Mendelian type or polymorphic character among the patients presenting a PVL+ necrotizing pneumonia (for immunogenetic study) [ Time Frame: at maximum 6 days after Sampling of blood and of serum ]
      genomic analysis an immunologic tests


    Original Secondary Outcome: Same as current

    Information By: Hospices Civils de Lyon

    Dates:
    Date Received: May 27, 2016
    Date Started: May 2011
    Date Completion: January 2017
    Last Updated: June 8, 2016
    Last Verified: May 2016