Staphylococcus (S.) Aureus Infection
Conditions
Keywords
antibiotic therapy, virulence factor adaptations, resistance development, genomic alterations of S. aureus
Brief summary
This study is to obtain a comprehensive view of S. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in S. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy.
Detailed description
Staphylococcus (S.) aureus is notorious for its ability to develop resistance. This study is to obtain a comprehensive view of S. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in S. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy. Patients with S. aureus infections who will routinely undergo diagnostic and surgical procedures will be identified. Intraoperative samples from the site of infection during surgery will be taken. Additionally, two blood drawing events (22.5ml in total) will be performed and nose swabs will be taken. The biological material will be analysed. This project will be the first to study different phenotypes of invasive S. aureus directly from its environment in vivo.
Interventions
OTHERdata collection
Health-related personal data such as year of birth, sex, Body Mass Index (BMI), infection classification, concomitant infections, comorbidities according to medical chart, standard diagnostic markers (CRP, blood differential plots, creatinine, ...), medication, treatment start, treatment end and discharge from hospital will be collected.
DIAGNOSTIC_TESTblood draw
2 blood drawing events (in total 22.5 ml) will be performed in the patient. 1 blood drawing events will be performed in the healthy proband.
DIAGNOSTIC_TESTnose swabs
2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.
DIAGNOSTIC_TESTIntraoperative tissue samples
Intraoperative tissue samples from the site of infection during surgery will be taken in the patient.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for patients: * In collaboration with the orthopedic surgeons, patients with probable or proven S. aureus infections will be identified who will routinely undergo diagnostic and surgical procedures: Inclusion criteria for healthy participants: * Healthy control group should be generally well-being
Exclusion criteria
for patients and for healthy participants: * Pregnancy: Pregnant or lactating women will be excluded (urinary pregnancy test will be performed in women of childbearing age) * General health condition: Current or recurrent disease that could cause complications that may affect the study or may set the patient at risk * Diseases/ Illness: Psychiatric or other mental disorders which in the opinion of the investigator may probably affect the full understanding of the study (including signs of dementia) * Language: Insufficient knowledge of german language to understand the procedure and rationale of the research question * Vulnerability: Individuals whose willingness to volunteer in the research project may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, such as members of a group with a direct hierarchical structure (refer to ICH Guidelines E6 (R1) for GCP, 1.61)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expression of virulence factors of S. aureus (derived from patient's samples (tissue, nose swab)) by combining highly sensitive mass spectrometry with whole genome sequencing. | Project duration for each patient will be two days | Expression of virulence factors of S. aureus (derived from patient's samples (tissue, nose swab)) by combining highly sensitive mass spectrometry with whole genome sequencing. There is neither a primary nor a secondary endpoint in this research project. |
| Antibiotics concentration | Project duration for each patient will be two days | Antibiotics concentration with chromatography methods (in tissue, blood) |
| Expression of genomic alterations of S. aureus (derived from patient's samples (tissue, nose swab)) by combining highly sensitive mass spectrometry with whole genome sequencing. | Project duration for each patient will be two days | Expression of genomic alterations of S. aureus (derived from patient's samples (tissue, nose swab)) by combining highly sensitive mass spectrometry with whole genome sequencing. There is neither a primary nor a secondary endpoint in this research project. |
Countries
Switzerland
Outcome results
None listed