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Completed

NCT Number: NCT02798497

Panton Valentine Leucocidin

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)

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Key information

Age range

2 month–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum and Blood samples

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. length of stay in Reanimation and ICU

    Time frame: number of days in Reanimation and ICU

    After hospitalisation, an average of 21 days

  3. length of stay in hospitalization

    Time frame: After hospitalisation, an average of 21 days

  4. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

Acronym: PVL

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2016
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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