Panton Valentine Leucocidin

Not Applicable

Completed

• Conditions: Staphylococcus Aureus Pneumonias
• Interventions: Other: Serum and Blood samples

• Registration Number: NCT02798497
• Lead Sponsor: Hospices Civils de Lyon

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)

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
staphylococcus aureus PVL-	Serum and Blood samples	patients with staphylococcus aureus PVL-
staphylococcus aureus PVL+	Serum and Blood samples	patients with staphylococcus aureus PVL+

Primary Outcome Measures

Name	Time	Method
The survival of the patients according to the character PVL+ or PVL- of the isolated Staphylococcus aureus strains	After hospitalisation, an average of 21 days	Percentage of alive patients after the length of stay in hospitalisation

Secondary Outcome Measures

Name	Time	Method
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
length of stay in Reanimation and ICU	number of days in Reanimation and ICU	After hospitalisation, an average of 21 days
length of stay in hospitalization	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)	at maximum 6 days after Sampling of blood and of serum	genomic analysis an immunologic tests

Trial Locations

Locations (1)

Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel; 🇫🇷 Bron, France