Clinical trial NCT04781569: Staphylococcus Aureus Caught in Action at the Site of Infection
Official title: A Single Centre, Unblinded, Prospective Cohort Study Identifying Pathogen Adaptations in Patients Suffering From Invasive S. Aureus Infection Compared to Colonized, Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus (S.) Aureus Infection
Keywords: antibiotic therapy
virulence factor adaptations
resistance development
genomic alterations of S. aureus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with probable or proven S. aureus infection will be screened at the University Hospital of Basel. Patients with confirmed S. aureus infection who correspond to the eligibility criteria will be asked to participate in the research project.

Healthy volunteers who correspond to the eligibility criteria will be asked to participate in the research project and recruited by oral communication from the institutions Biozentrum, University Hospital Basel, and University of Basel.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: Project duration for each patient will be two days
measure: Antibiotics concentration
timeFrame: Project duration for each patient will be two days
measure: 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.
timeFrame: Project duration for each patient will be two days
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Nina Khanna, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: