NCT04318262

Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients

Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcus Lugdunensis Infection

Interventions

Type	Name	Description
BIOLOGICAL	Determination of the clinical and biological characteristics	* clinical data: types of infections (skin and soft tissues, bone and joint, bacteraemia, endocarditis…), delay between clinical signs and hospitalization, number of days of fever, number of days of hospitalization, infectious complications… * biological data: Haemoglobin, Leucocytes, Neutrophils, Creatinine clearance, CRP…
BIOLOGICAL	Description of the antibiotic resistance profile	Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
BIOLOGICAL	Molecular epidemiology of S. lugdunensis infections	Genome sequencing (Illumina technique)

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-03-23
• Last updated: 2020-06-30

Locations

2 sites across 1 country: France