Staphylococcus Aureus Caught in Action at the Site of Infection

NCT ID: NCT04781569

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2020-11-23

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.

Conditions

Staphylococcus (S.) Aureus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with S. aureus infection

data collection

Intervention Type: OTHER

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.

blood draw

Intervention Type: DIAGNOSTIC_TEST

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.

nose swabs

Intervention Type: DIAGNOSTIC_TEST

2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.

Intraoperative tissue samples

Intervention Type: DIAGNOSTIC_TEST

Intraoperative tissue samples from the site of infection during surgery will be taken in the patient.

healthy participants

data collection

Intervention Type: OTHER

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.

blood draw

Intervention Type: DIAGNOSTIC_TEST

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.

nose swabs

Intervention Type: DIAGNOSTIC_TEST

2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.

Interventions

data 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.

Intervention Type: OTHER

blood 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.

Intervention Type: DIAGNOSTIC_TEST

nose swabs

2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.

Intervention Type: DIAGNOSTIC_TEST

Intraoperative tissue samples

Intraoperative tissue samples from the site of infection during surgery will be taken in the patient.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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:

• Healthy control group should be generally well-being

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Khanna, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2017-00793; me20Khanna

Identifier Type: -

Identifier Source: org_study_id