Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients
NCT ID: NCT04318262
Last Updated: 2020-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2020-09-30
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patient with Staphylococcus lugdunensis infection
All consecutive patients with S. lugdunensis infection (microbiological and clinical data)
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…
Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
Molecular epidemiology of S. lugdunensis infections
Genome sequencing (Illumina technique)
Patient with Staphylococcus aureus infection
Patients with S. aureus infection (microbiological and clinical data), matched to the hospital sector for S. lugdunensis infections
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…
Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
Patient with other coagulase negative Staphylococcus infection
Patients with CoNS infection (microbiological and clinical data),matched to the hospital sector for S. lugdunensis infections
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…
Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
Interventions
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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…
Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
Molecular epidemiology of S. lugdunensis infections
Genome sequencing (Illumina technique)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* Patient not affiliated to the French Social Security system
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Sandrine DAHYOT
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Caen University Hospital
Caen, , France
Rouen University Hospital
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Christophe ISNARD, Dr
Role: primary
Other Identifiers
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2018/416/OB
Identifier Type: -
Identifier Source: org_study_id
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