Staphylococcus (S.) Aureus InfectionPROSANCT04781569
Staphylococcus Aureus Caught in Action at the Site of Infection
An observational study of Staphylococcus (S.) Aureus Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus (S.) Aureus Infection
- What is being tested?
- data collection, blood draw and nose swabs
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jun 2017to 23 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- data collection, blood draw, nose swabs, Intraoperative tissue samples
- Keywords
- antibiotic therapy, virulence factor adaptations, resistance development, genomic alterations of S. aureus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
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 drawDiagnostic 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 swabsDiagnostic test
2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.
Intraoperative tissue samplesDiagnostic test
Intraoperative tissue samples from the site of infection during surgery will be taken in the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with S. aureus infection | Not described Receives: Other: data collection; Diagnostic Test: blood draw; Diagnostic Test: nose swabs; Diagnostic Test: Intraoperative tissue samples | |
| healthy participants | Not described Receives: Other: data collection; Diagnostic Test: blood draw; Diagnostic Test: nose swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Project duration for each patient will be two days
Antibiotics concentration
Antibiotics concentration with chromatography methods (in tissue, blood)
Measured: 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.
Measured: Project duration for each patient will be two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start6 Jun 2017
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus (S.) Aureus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Khanna, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781569
- Sponsor's protocol ID
- 2017-00793; me20Khanna
- Other IDs
- 2017
- Acronym
- PROSA
- Status last verified
- Jun 2021
- First submitted
- 23 Feb 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04781569
- Acronym / sponsor ID
- PROSA / 2017-00793; me20Khanna
- Conditions
- Staphylococcus (S.) Aureus Infection
- Keywords
- antibiotic therapy, virulence factor adaptations, resistance development, genomic alterations of S. aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionHealth-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. | Other | Patients with S. aureus infection, healthy participants |
| blood draw2 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 test | Patients with S. aureus infection, healthy participants |
| nose swabs2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband. | Diagnostic test | Patients with S. aureus infection, healthy participants |
| Intraoperative tissue samplesIntraoperative tissue samples from the site of infection during surgery will be taken in the patient. | Diagnostic test | Patients with S. aureus infection |
Primary outcome
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Khanna, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus (S.) Aureus Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Project duration for each patient will be two days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.