Staphylococcus (S.) Aureus Infection Clinical Trial
— PROSAOfficial title:
A Single Centre, Unblinded, Prospective Cohort Study Identifying Pathogen Adaptations in Patients Suffering From Invasive S. Aureus Infection Compared to Colonized, Healthy Individuals
| Verified date | June 2021 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | November 23, 2020 |
| Est. primary completion date | November 23, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Antibiotics concentration | Antibiotics concentration with chromatography methods (in tissue, blood) | Project duration for each patient will be two days | |
| Primary | 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 |