Panton Valentine Leucocidin (PVL)

September 2, 2025 updated by: Hospices Civils de Lyon

Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: staphylococcus aureus PVL-
patients with staphylococcus aureus PVL-
Other: Serum and Blood samples
Other: staphylococcus aureus PVL+
patients with staphylococcus aureus PVL+
Other: Serum and Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After hospitalisation, an average of 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
number of days in Reanimation and ICU
length of stay in hospitalization
Time Frame: After hospitalisation, an average of 21 days
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
at maximum 6 days after Sampling of blood and of serum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • As designed, the study enrolled a cohort of 154 evaluable patients. In the adult subgroup, there was a balanced distribution between pneumonia caused by Staphylococcus aureus that was Panton-Valentine leukocidin (PVL)-positive and PVL-negative. This balanced allocation will enable a refined assessment of the PVL effect in this condition. Preliminary results appear to support the working hypothesis (mortality 45% in PVL-positive vs 26.3% in PVL-negative cases; p < 0.05). In addition, biospecimens were collected from 98 patients for subsequent genetic analyses.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

December 21, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010.625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Staphylococcus Aureus Pneumonias

Clinical Trials on Serum and Blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe