Panton Valentine Leucocidin (PVL)
Primary Purpose
Staphylococcus Aureus Pneumonias
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serum and Blood samples
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcus Aureus Pneumonias focused on measuring PVL, Pneumonias, Staphylococcus aureus
Eligibility Criteria
Inclusion Criteria:
- 2-month-old patient at minimum and weighing at least 5 kg
- Informed consent
- Subjects affiliated (or beneficiary) to a national medical insurance
- Presence of clinical, biological and radiological signs of pneumopathy to S. aureus whose clinical state justifies a hospitalization in a ICU or in a reanimation
- Presence of PVL- positive S.aureus producer (for immunogenetic study)
Exclusion Criteria:
- Patients infected by the HIV
- Patients hospitalized for more than 48 hours at the time of the diagnosis of pneumonia,
- Patients hospitalized during the previous three months excepted outpatients
Sites / Locations
- Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
staphylococcus aureus PVL-
staphylococcus aureus PVL+
Arm Description
patients with staphylococcus aureus PVL-
patients with staphylococcus aureus PVL+
Outcomes
Primary Outcome Measures
The survival of the patients according to the character PVL+ or PVL- of the isolated Staphylococcus aureus strains
Percentage of alive patients after the length of stay in hospitalisation
Secondary Outcome Measures
Gravity Scores : Composite measure between the IGS2 and SOFA scores for an adult and between PIM2 and PLEOD scores for a child
length of stay in Reanimation and ICU
After hospitalisation, an average of 21 days
length of stay in hospitalization
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)
genomic analysis an immunologic tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02798497
Brief Title
Panton Valentine Leucocidin
Acronym
PVL
Official Title
Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 sampled for immune genetic studies (ORFeome sequencing and functional studied)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Pneumonias
Keywords
PVL, Pneumonias, Staphylococcus aureus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
staphylococcus aureus PVL-
Arm Type
Other
Arm Description
patients with staphylococcus aureus PVL-
Arm Title
staphylococcus aureus PVL+
Arm Type
Other
Arm Description
patients with staphylococcus aureus PVL+
Intervention Type
Other
Intervention Name(s)
Serum and Blood samples
Primary Outcome Measure Information:
Title
The survival of the patients according to the character PVL+ or PVL- of the isolated Staphylococcus aureus strains
Description
Percentage of alive patients after the length of stay in hospitalisation
Time Frame
After hospitalisation, an average of 21 days
Secondary Outcome Measure Information:
Title
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
Title
length of stay in Reanimation and ICU
Description
After hospitalisation, an average of 21 days
Time Frame
number of days in Reanimation and ICU
Title
length of stay in hospitalization
Time Frame
After hospitalisation, an average of 21 days
Title
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)
Description
genomic analysis an immunologic tests
Time Frame
at maximum 6 days after Sampling of blood and of serum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2-month-old patient at minimum and weighing at least 5 kg
Informed consent
Subjects affiliated (or beneficiary) to a national medical insurance
Presence of clinical, biological and radiological signs of pneumopathy to S. aureus whose clinical state justifies a hospitalization in a ICU or in a reanimation
Presence of PVL- positive S.aureus producer (for immunogenetic study)
Exclusion Criteria:
Patients infected by the HIV
Patients hospitalized for more than 48 hours at the time of the diagnosis of pneumonia,
Patients hospitalized during the previous three months excepted outpatients
Facility Information:
Facility Name
Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
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Panton Valentine Leucocidin
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