Staphylococcus Lugdunensis Infection Clinical Trial
— INHOSTALOfficial title:
Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study
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.
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Caen University Hospital | Caen | |
| France | Rouen University Hospital | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Staphylococcus lugdunensis infections in hospitalized patients | Number of patients with S. lugdunensis infection during the study period, relative to the total number of patients hospitalized during the study period | 24 months | |
| Secondary | Clinical epidemiology of S. lugdunensis infections compared to that of S. aureus and other CoNS species | 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 |
24 months | |
| Secondary | Current pattern of antibiotic resistance of S. lugdunensis, S. aureus and other CoNS species | 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. |
24 months | |
| Secondary | Molecular epidemiology of S. lugdunensis infections | Search for epidemic strains of S. lugdunensis in the Normandy region by comparative genomic analysis (high-throughput genome sequencing by Illumina technique) | 24 months |