Staphylococcus Lugdunensis InfectionINHOSTALNCT04318262
Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients
An observational study of Staphylococcus Lugdunensis Infection, run by University Hospital, Rouen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Lugdunensis Infection
- What is being tested?
- Determination of the clinical and biological characteristics, Description of the antibiotic resistance profile and Molecular epidemiology of S. lugdunensis infections
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patient with Staphylococcus lugdunensis infection
Who may be able to join
- 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…)
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Caen University Hospital
Caen
Christophe ISNARD, Dr
Christophe ISNARD, Dr
Rouen University Hospital
Rouen
Sandrine DAHYOT, Dr, sandrine.dahyot@chu-rouen.fr
Martine PESTEL-CARON, Pr
About this study
Official 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.
Read more
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.
- Conditions
- Staphylococcus Lugdunensis Infection
- Being tested
- Determination of the clinical and biological characteristics, Description of the antibiotic resistance profile, Molecular epidemiology of S. lugdunensis infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of the clinical and biological characteristicsBiological
- 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 profileBiological
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
Molecular epidemiology of S. lugdunensis infectionsBiological
Genome sequencing (Illumina technique)
| Study group | Role | What they receive |
|---|---|---|
| Patient with Staphylococcus lugdunensis infection | All consecutive patients with S. lugdunensis infection (microbiological and clinical data) Receives: Biological: Determination of the clinical and biological characteristics; Biological: Description of the antibiotic resistance profile; Biological: Molecular epidemiology of S. lugdunensis infections | |
| Patient with Staphylococcus aureus infection | Patients with S. aureus infection (microbiological and clinical data), matched to the hospital sector for S. lugdunensis infections Receives: Biological: Determination of the clinical and biological characteristics; Biological: Description of the antibiotic resistance profile | |
| Patient with other coagulase negative Staphylococcus infection | Patients with CoNS infection (microbiological and clinical data),matched to the hospital sector for S. lugdunensis infections Receives: Biological: Determination of the clinical and biological characteristics; Biological: Description of the antibiotic resistance profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 months
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.
Measured: 24 months
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Lugdunensis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine DAHYOT, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318262
- Sponsor's protocol ID
- 2018/416/OB
- Acronym
- INHOSTAL
- Status last verified
- Jun 2020
- First submitted
- 20 Mar 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study
- ClinicalTrials.gov ID
- NCT04318262
- Acronym / sponsor ID
- INHOSTAL / 2018/416/OB
- Conditions
- Staphylococcus Lugdunensis Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with Staphylococcus lugdunensis infection | – | Biological: Determination of the clinical and biological characteristics, Biological: Description of the antibiotic resistance profile, Biological: Molecular epidemiology of S. lugdunensis infectionsAll consecutive patients with S. lugdunensis infection (microbiological and clinical data) |
| Patient with Staphylococcus aureus infection | – | Biological: Determination of the clinical and biological characteristics, Biological: Description of the antibiotic resistance profilePatients with S. aureus infection (microbiological and clinical data), matched to the hospital sector for S. lugdunensis infections |
| Patient with other coagulase negative Staphylococcus infection | – | Biological: Determination of the clinical and biological characteristics, Biological: Description of the antibiotic resistance profilePatients with CoNS infection (microbiological and clinical data),matched to the hospital sector for S. lugdunensis infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patient with Staphylococcus lugdunensis infection
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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… | Biological | Patient with Staphylococcus aureus infection, Patient with Staphylococcus lugdunensis infection, Patient with other coagulase negative Staphylococcus infection |
| Description of the antibiotic resistance profileDetermination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique | Biological | Patient with Staphylococcus aureus infection, Patient with Staphylococcus lugdunensis infection, Patient with other coagulase negative Staphylococcus infection |
| Molecular epidemiology of S. lugdunensis infectionsGenome sequencing (Illumina technique) | Biological | Patient with Staphylococcus lugdunensis infection |
Primary outcome
Incidence of Staphylococcus lugdunensis infections in hospitalized patients
Time frame: 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
3 secondary outcomes
Clinical epidemiology of S. lugdunensis infections compared to that of S. aureus and other CoNS species
Time frame: 24 months
Current pattern of antibiotic resistance of S. lugdunensis, S. aureus and other CoNS species
Time frame: 24 months
Molecular epidemiology of S. lugdunensis infections
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine DAHYOT principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Lugdunensis Infection, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine DAHYOT (+3323288 ext. 8265, sandrine.dahyot@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Staphylococcus lugdunensis infections in hospitalized patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.