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Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients (INHOSTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318262
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment
Staphylococcus Lugdunensis Infection Biological: Determination of the clinical and biological characteristics Biological: Description of the antibiotic resistance profile Biological: Molecular epidemiology of S. lugdunensis infections

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Patient with Staphylococcus lugdunensis infection
All consecutive patients with S. lugdunensis infection (microbiological and clinical data)
Biological: 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: Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique

Biological: 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
Biological: 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: 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
Biological: 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: Description of the antibiotic resistance profile
Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical epidemiology of S. lugdunensis infections compared to that of S. aureus and other CoNS species [ Time Frame: 24 months ]

    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


  2. Current pattern of antibiotic resistance of S. lugdunensis, S. aureus and other CoNS species [ Time Frame: 24 months ]
    • 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.

  3. Molecular epidemiology of S. lugdunensis infections [ Time Frame: 24 months ]
    Search for epidemic strains of S. lugdunensis in the Normandy region by comparative genomic analysis (high-throughput genome sequencing by Illumina technique)


Biospecimen Retention:   Samples Without DNA
Staphylococcus lugdunensis, Staphylococcus aureus or others coagulase negative Staphylococcus (CoNS) species


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patient with Staphylococcus lugdunensis infection
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318262


Contacts
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Contact: Sandrine DAHYOT +3323288 ext 8265 sandrine.dahyot@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
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France
Caen University Hospital
Caen, France
Contact: Christophe ISNARD, Dr         
Principal Investigator: Christophe ISNARD, Dr         
Rouen University Hospital
Rouen, France
Contact: Sandrine DAHYOT, Dr       sandrine.dahyot@chu-rouen.fr   
Sub-Investigator: Martine PESTEL-CARON, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Sandrine DAHYOT Rouen University Hospital
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04318262    
Other Study ID Numbers: 2018/416/OB
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents