UnknownNot Applicable

Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients

France300 participantsStarted 2020-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Staphylococcus lugdunensis infections in hospitalized patients

Timeframe: 24 months

Trial details

NCT IDNCT04318262

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12

Contact for this trial

Sandrine DAHYOT

+3323288 sandrine.dahyot@chu-rouen.fr

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