Staphylococcus Aureus PneumoniasPVLNCT02798497
Panton Valentine Leucocidin
A study testing Serum and Blood samples in people with Staphylococcus Aureus Pneumonias, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 100 years
- Conditions the study is for
- Staphylococcus Aureus Pneumonias
- What is being tested?
- Serum and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to 21 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel
Bron, 69677
About this study
Official title: 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)
- Conditions
- Staphylococcus Aureus Pneumonias
- Being tested
- Serum and Blood samples
- Keywords
- PVL, Pneumonias, Staphylococcus aureus
- Medical subject headings
- Pneumonia, Staphylococcal, Pneumonia, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| staphylococcus aureus PVL- | Other | patients with staphylococcus aureus PVL- Receives: Other: Serum and Blood samples |
| staphylococcus aureus PVL+ | Other | patients with staphylococcus aureus PVL+ Receives: Other: Serum and Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After hospitalisation, an average of 21 days
Secondary outcomes (4)
Gravity Scores : Composite measure between the IGS2 and SOFA scores for an adult and between PIM2 and PLEOD scores for a child
Measured: At admission at Reanimation Unit or ICU, at 24 h after admission and 7 days after admission
length of stay in Reanimation and ICU
After hospitalisation, an average of 21 days
Measured: number of days in Reanimation and ICU
length of stay in hospitalization
Measured: 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)
genomic analysis an immunologic tests
Measured: at maximum 6 days after Sampling of blood and of serum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2011
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus PneumoniasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798497
- Sponsor's protocol ID
- 2010.625
- Acronym
- PVL
- Status last verified
- Sep 2025
- First submitted
- 27 May 2016
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias
- ClinicalTrials.gov ID
- NCT02798497
- Acronym / sponsor ID
- PVL / 2010.625
- Conditions
- Staphylococcus Aureus Pneumonias
- Keywords
- PVL, Pneumonias, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| staphylococcus aureus PVL- | Other | Other: Serum and Blood samplespatients with staphylococcus aureus PVL- |
| staphylococcus aureus PVL+ | Other | Other: Serum and Blood samplespatients with staphylococcus aureus PVL+ |
Who may qualify
- Ages
- 2 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum and Blood samples | Other | staphylococcus aureus PVL+, staphylococcus aureus PVL- |
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
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publicationAs 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum and Blood samples in people with Staphylococcus Aureus Pneumonias, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.