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Panton Valentine Leucocidin

Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02798497
Acronym
PVL
Enrollment
234
Registered
2016-06-14
Start date
2011-05-31
Completion date
2016-12-21
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus Aureus Pneumonias

Keywords

PVL, Pneumonias, Staphylococcus aureus

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)

Interventions

OTHERSerum and Blood samples

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The survival of the patients according to the character PVL+ or PVL- of the isolated Staphylococcus aureus strainsAfter hospitalisation, an average of 21 daysPercentage of alive patients after the length of stay in hospitalisation

Secondary

MeasureTime frameDescription
Gravity Scores : Composite measure between the IGS2 and SOFA scores for an adult and between PIM2 and PLEOD scores for a childAt admission at Reanimation Unit or ICU, at 24 h after admission and 7 days after admission
length of stay in Reanimation and ICUnumber of days in Reanimation and ICUAfter hospitalisation, an average of 21 days
length of stay in hospitalizationAfter 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)at maximum 6 days after Sampling of blood and of serumgenomic analysis an immunologic tests

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026