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ClinicalTrials.gov ID

NCT04318262

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Jun 30, 2020Actual

Start Date

Sep 2020Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

Official Title

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

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.

• Staphylococcus Lugdunensis Infection

• Determination of the clinical and biological characteristics
• Description of the antibiotic resistance profile
• Molecular epidemiology of S. lugdunensis infections

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

University Hospital, RouenOTHER

sandrine.dahyot@chu-rouen.fr