Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients

• Conditions: Staphylococcus Lugdunensis Infection

• Registration Number: NCT04318262
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30
• Study Start: 2020-09
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Staphylococcus lugdunensis infections in hospitalized patients	24 months	Number of patients with S. lugdunensis infection during the study period, relative to the total number of patients hospitalized during the study period

Secondary Outcome Measures

Name	Time	Method
Current pattern of antibiotic resistance of S. lugdunensis, S. aureus and other CoNS species	24 months	* For S. lugdunensis, S. aureus and other CoNS species: resistance rate to major anti-staphylococcal antibiotics according to the determination of MICs by the Sensititre technique; * For S. lugdunensis: description of the molecular mechanisms of antibiotic resistance from whole genome sequencing data.
Molecular epidemiology of S. lugdunensis infections	24 months	Search for epidemic strains of S. lugdunensis in the Normandy region by comparative genomic analysis (high-throughput genome sequencing by Illumina technique)
Clinical epidemiology of S. lugdunensis infections compared to that of S. aureus and other CoNS species	24 months	Comparative description of infections: * Clinical and biological characteristics; * Frequency of community- and healthcare-associated infections; * Antibiotic management and frequency of drainage and surgical procedures; Identification of risk factors associated with infections caused by S. lugdunensis, S. aureus and other CoNS species: description of the demographic characteristics, clinical features, history of the disease, and comorbidities

Trial Locations

Locations (2)

Caen University Hospital; 🇫🇷 Caen, France

Rouen University Hospital; 🇫🇷 Rouen, France