Clinical trial NCT04318262: Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients
Official title: Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Lugdunensis Infection
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patient with Staphylococcus lugdunensis infection

Brief summary: Staphylococcus lugdunensis is a coagulase-negative Staphylococcus (CoNS) belonging to the normal human skin flora. It is responsible for a wide variety of infections, such as skin and soft tissue infections, bone and joint infections, but also bacteraemia and endocarditis. Although the implication of S. lugdunensis in infectious diseases is proven, many questions remain both in terms of clinical and molecular epidemiology.

In this context, INHOSTAL is the first prospective, bicentric study, which will comprehensively include all patients with S. lugdunensis infection (based on microbiological and clinical data) in two French university hospitals. The main objective of this study is thus to determine the incidence of S. lugdunensis infections in hospitalized patients.

Moreover, the originality of this project is to compare the characteristics of S. lugdunensis infections with those of infections caused by S. aureus and other species of CoNS. Thereby, the clinical epidemiology of these infections will be compared (i.e. types of infection, mode of acquisition, host risk factors...).

Finally, complete genome of all S. lugdunensis strains will be sequenced using Illumina technology and analyzed to describe the molecular epidemiology as well as the molecular mechanisms of antibiotic resistance (compared to antibiotic susceptibility evaluated by minimum inhibitory concentrations determined by Sensititre technique). This will enable to identify if predominant clones exist, and if some strains are spreading into the hospital.

The duration of the study period will be 18 months, to allow the inclusion of a total of 300 patients: 100 S. lugdunensis infections, as well as 100 S. aureus infections and 100 other species of CoNS infections.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized patients
* Patients with clinical criteria for infection
* Patients with at least one of the following microbiological criteria for infection caused by S. lugdunensis, S. aureus or other CoNS species:
* Pure culture in a normally sterile site excluding blood culture
* At least two blood cultures or one blood culture positive and a context of endocarditis or colonized material (catheter, pace-maker...)
* Pure or predominant positive culture (probable infection) in a superficial skin sample taken by swab
* At least two surgical positive cultures in case of osteo-articular infection
* Pure positive urine culture (≥104 CFU / mL), in association with abnormal leukocyturia (≥ 104 / mL)
* Patients (or trusted person) who have read the information note and who do not oppose to research participation
* Patient affiliated to the French Social Security system

Exclusion Criteria:

* Age \<18 years
* Patient not affiliated to the French Social Security system
* Patient with a positive culture for S. lugdunensis, S. aureus or other CoNS species but who does not meet the inclusion criteria defined above
* Pulmonary infections of patients with cystic fibrosis
* Patient already included in the study for an infection caused by S. lugdunensis, S. aureus or other CoNS species
* Person deprived of their liberty by an administrative or judicial decision, person placed under the protection of justice, guardianship or curatorship.

Primary outcomes:
measure: Incidence of Staphylococcus lugdunensis infections in hospitalized patients
timeFrame: 24 months
Secondary outcomes:
measure: Clinical epidemiology of S. lugdunensis infections compared to that of S. aureus and other CoNS species
timeFrame: 24 months
measure: Current pattern of antibiotic resistance of S. lugdunensis, S. aureus and other CoNS species
timeFrame: 24 months
measure: Molecular epidemiology of S. lugdunensis infections
timeFrame: 24 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Sandrine DAHYOT
role: PRINCIPAL_INVESTIGATOR
References: