Staphylococcus Aureus Caught in Action at the Site of Infection

NCT04781569 | Completed

• 1 other identifier: 2017-00793; me20Khanna
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus (S.) Aureus Infection

Keywords

antibiotic therapy; virulence factor adaptations; resistance development; genomic alterations of S. aureus

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Project duration for each patient will be two days

• Antibiotics concentration

  Antibiotics concentration with chromatography methods (in tissue, blood)

  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.

  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.

  Project duration for each patient will be two days

Study Arms (2)

Patients with S. aureus infection

Other: data collection; Diagnostic Test: blood draw; Diagnostic Test: nose swabs; Diagnostic Test: Intraoperative tissue samples

healthy participants

Other: data collection; Diagnostic Test: blood draw; Diagnostic Test: nose swabs

Interventions

data collection 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.

Patients with S. aureus infection; healthy participants

blood draw 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.

Patients with S. aureus infection; healthy participants

nose swabs DIAGNOSTIC_TEST

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

Patients with S. aureus infection; healthy participants

Intraoperative tissue samples DIAGNOSTIC_TEST

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

Patients with S. aureus infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Data Collection; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Nina Khanna, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: June 6, 2017
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

CH (1)