Staphylococcus Aureus Pneumonias Clinical Trial
— PVLOfficial title:
Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias
| NCT number | NCT02798497 |
| Other study ID # | 2010.625 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2011 |
| Est. completion date | December 21, 2016 |
| Verified date | March 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | December 21, 2016 |
| Est. primary completion date | December 21, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Months to 100 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | After hospitalisation, an average of 21 days | |
| Secondary | Gravity Scores : Composite measure between the IGS2 and SOFA scores for an adult and between PIM2 and PLEOD scores for a child | At admission at Reanimation Unit or ICU, at 24 h after admission and 7 days after admission | ||
| Secondary | length of stay in Reanimation and ICU | After hospitalisation, an average of 21 days | number of days in Reanimation and ICU | |
| Secondary | length of stay in hospitalization | After hospitalisation, an average of 21 days | ||
| Secondary | 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 | at maximum 6 days after Sampling of blood and of serum |