Staphylococcus Aureus InfectionTARGET IINCT04503252
Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus
An observational study of Staphylococcus Aureus Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Given the paucity of pharmacological data on cefazolin treatment of Methicillin-susceptible S. aureus (MSSA) complicated S. aureus infection (CSAI), the primary purpose of this study is to investigate the probability of pharmacological target attainment (in the blood and infected tissue) with standard intermittent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Infection
- What is being tested?
- Blood samples for the measurement of the concentration of cefazolin, S. aureus culture isolate and structured telephone interview
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jan 2020to 28 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with CSAI fulfilling the inclusion criteria and admitted at the University Hospital Basel.
Who may be able to join
- CSAI caused by MSSA. CSAI is defined as MSSA BSI with a positive follow-up blood culture result for MSSA or the presence of a site of infection remote from the primary focus caused by hematogenous seeding (e.g. endocarditis, vertebral osteomyelitis) or extension of the infection beyond the primary focus (e.g. septic thrombophlebitis or abscess); or deep-seated infections caused by MSSA (e.g. osteoarticular infections, deepseated abscesses).
- Current or intended treatment with cefazolin
Who cannot join
- Previous enrolment into the current study within 30 days
- Hemodialysis (patients on hemofiltration are eligible)
- Patients who are very likely to stop treatment with cefazolin in the next 48 hours as per treating physician (because of treatment failure, switch to oral medication, palliative care, allergy etc.) or who are very likely to be discharged in the next 48 hours as per treating physician.
- Outpatients
- Women who are pregnant (special pharmacokinetic)
- Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Propionibacterium acnes) or an anaerobic pathogen. If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
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- Not-complicated S. aureus infections: non-bacteremic skin- and soft tissue or small Joint infections without deep-seated abscesses (as these patients will be quickly switched to oral antibiotics)
- CSAI caused by methicillin-resistant S. aureus (MRSA)
- Additional exclusion criteria for the sub-study investigating cefazolin concentrations in sweat:
- Allergic to pilocarpine
- Continuous oxygen therapy without the possibility to interrupt oxygen administration for 10min
- Pacemaker
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Internal Medicine
Basel, 4031
About this study
Official title: Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus: A Prospective Single-center Cohort Study
Given the paucity of pharmacological data on cefazolin treatment of Methicillin-susceptible S. aureus (MSSA) complicated S. aureus infection (CSAI), the primary purpose of this study is to investigate the probability of pharmacological target attainment (in the blood and infected tissue) with standard intermittent bolus administration of cefazolin in patients with CSAI caused by MSSA by determining plasma concentrations of cefazolin and exact Minimum inhibitory concentration (MICs) of the causative MSSA strains in patients with various disease severities (e.g. critically ill vs. noncritically ill patients).
- Sub-study quantitative measurement of Torque Teno virus (TTV): The primary purpose of this sub-study is to describe the viral kinetics of TTV in CSAI patients and to explore the association of TTV viremia with clinical outcomes and molecular markers of activation of the immune system.
- Sub-study investigating antibiotic concentrations in sweat as a non-invasive therapeutic drug monitoring
- Conditions
- Staphylococcus Aureus Infection
- Being tested
- Blood samples for the measurement of the concentration of cefazolin, S. aureus culture isolate, structured telephone interview, Sub-study quantitative measurement of Torque Teno virus, Sub-study investigating cefazolin concentrations in sweat
- Keywords
- Bloodstream infection (BSI), Minimum inhibitory concentration (MIC), Methicillin-susceptible S. aureus (MSSA), Staphylococcus aureus (S. aureus), β-lactam antibiotics, flucloxacillin, cefazolin, pharmacological target attainment, Torque Teno virus (TTV), Therapeutic drug monitoring (TDM), antibiotic sweat concentrations, Complicated S. aureus infection (CSAI)
- Medical subject headings
- Staphylococcal Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for the measurement of the concentration of cefazolinOther
Blood samples for the measurement of the concentration of cefazolin will be collected on the 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (usually within 4 weeks after inclusion; only in patients on outpatient continuous parenteral antibiotic treatment).
S. aureus culture isolateOther
The S. aureus culture isolate will be subjected to exact cefazolin MIC determination and to measurement of the level of cefazolin tolerance.
structured telephone interviewOther
Structured telephone interview for Patient follow- up after 30 days
Sub-study quantitative measurement of Torque Teno virusOther
An additional EDTA sample will be drawn for quantitative polymerase chain reaction (PCR) of TTV DNA and analyses of cytokines and other parameters of the activation state of the immune system.
Sub-study investigating cefazolin concentrations in sweatOther
For each visit of included patients, a sweat sample will be collected via a CE certified Macroduct Sweat Collector. Eccrine sweat glands of the lower forearms are stimulated by pilocarpine (a parasympathomimetic) as well as a local current for 5min. Sweat is subsequently collected by capillary containers during 30min and transferred to small tubes on dry ice. Sweat sample analysis is conducted using mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Study population: patients with CSAI caused by MSSA | Inpatients with CSAI caused by MSSA treated or intended to receive cefazolin within the next 24-48 hours (at least 10 (maximum of 20) critically-ill patients, at least 10 (maximum of 20) patients with an estimated glomerular filtration rate of <60ml/min, at least 10 patients with BSI). Receives: Other: Blood samples for the measurement of the concentration of cefazolin; Other: S. aureus culture isolate; Other: structured telephone interview | |
| Sub-study: Torque Teno virus (TTV) viremia | TTV viral load may indicate the immunological status of the host. The TTV sub-study is to to describe the viral kinetics of TTV in CSAI patients. Receives: Other: Blood samples for the measurement of the concentration of cefazolin; Other: S. aureus culture isolate; Other: structured telephone interview; Other: Sub-study quantitative measurement of Torque Teno virus | |
| Sub-study: cefazolin concentrations in sweat | Out of the study population (patients with CSAI) a total of 15 CSAI patients will be included for the substudy investigating cefazolin concentrations in sweat as a non-invasive therapeutic drug monitoring. Receives: Other: Blood samples for the measurement of the concentration of cefazolin; Other: S. aureus culture isolate; Other: structured telephone interview; Other: Sub-study investigating cefazolin concentrations in sweat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough concentration of cefazolin in plasma samples
Trough concentration of cefazolin measured in plasma samples
Measured: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Total plasma concentrations of cefazolin in plasma samples
Total plasma concentrations of cefazolin in plasma samples
Measured: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Free drug concentrations of cefazolin in plasma samples
Free drug concentrations of cefazolin in plasma samples
Measured: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Trough concentration of cefazolin in sweat samples
Trough concentration of cefazolin measured in sweat samples
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Total sweat concentrations of cefazolin
Total sweat concentrations of cefazolin
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Free drug concentrations of cefazolin in sweat samples
Free drug concentrations of cefazolin in sweat samples
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Target attainment (100%fT>MIC)
Antibiotic susceptibility of the isolated pathogens determined by the use of an Minimum inhibitory concentration (MIC) test strip. Target attainment (100%fT>MIC) will be calculated for each patient and for each day the patient was sampled. Target attainment is defined as a measured free trough plasma concentration of cefazolin above the measured exact MICs of the causative pathogens at all points of time sampled.
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Secondary outcomes (5)
Pharmacological target attainment (100%fT>MIC) in infected tissue
For the analysis of pharmacological target attainment (100%fT>MIC) in infected tissue (only patients with a suggestive focus or metastatic complication of BSI will be included for this analysis) free trough concentration of cefazolin will be measured in plasma samples.
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Attainment of an accepted threshold for toxicity (100%fT>10xMIC) in blood
For the analysis of attainment of an accepted threshold for toxicity (100%fT>10xMIC) in blood, trough free concentration of cefazolin will be measured in plasma samples. Attainment of the threshold for toxicity is defined as measured free trough plasma concentration of cefazolin above at least 10x the measured exact MIC or above the clinical breakpoint MIC of the causative pathogen as published by the European Committee on Antimicrobial Susceptibility Testing at one time point or more. Cefazolin concentrations in sweat will be compared between patients with attained toxicity and non-attained thresholds in plasma.
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Level of cefazolin tolerance of the isolated pathogen
The level of cefazolin tolerance of the isolated pathogen will be determined by the tolerance disc test as well as through time-kill curves. The level of tolerance determines the required antibiotic concentration to achieve bactericidal killing.
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
TTV substudy: quantification of DNA
For the TTV substudy DNA will be extracted from ethylenediaminetetraacetic acid (EDTA) blood and quantified
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
TTV substudy: quantification of cytokines
Cytokines as a markers of the activation status of the immune system will be quantified by using commercially available ELISA kits.
Measured: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start14 Jan 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- propatient foundation Basel
- Responsible party
- Sponsor
- Investigators
- Michael Osthoff, PD Dr. med., Principal investigator, University Hospital Basel, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503252
- Sponsor's protocol ID
- 2019-02229; me20Osthoff2
- Other IDs
- 2019
- Acronym
- TARGET II
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2020
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus: A Prospective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT04503252
- Acronym / sponsor ID
- TARGET II / 2019-02229; me20Osthoff2
- Conditions
- Staphylococcus Aureus Infection
- Keywords
- Bloodstream infection (BSI), Minimum inhibitory concentration (MIC), Methicillin-susceptible S. aureus (MSSA), Staphylococcus aureus (S. aureus), β-lactam antibiotics, flucloxacillin, cefazolin, pharmacological target attainment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- propatient foundation Basel
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 7 Aug 2020 (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.
Given the paucity of pharmacological data on cefazolin treatment of Methicillin-susceptible S. aureus (MSSA) complicated S. aureus infection (CSAI), the primary purpose of this study is to investigate the probability of pharmacological target attainment (in the blood and infected tissue) with standard intermittent bolus administration of cefazolin in patients with CSAI caused by MSSA by determining plasma concentrations of cefazolin and exact Minimum inhibitory concentration (MICs) of the causative MSSA strains in patients with various disease severities (e.g. critically ill vs. noncritically ill patients).
- Sub-study quantitative measurement of Torque Teno virus (TTV): The primary purpose of this sub-study is to describe the viral kinetics of TTV in CSAI patients and to explore the association of TTV viremia with clinical outcomes and molecular markers of activation of the immune system.
- Sub-study investigating antibiotic concentrations in sweat as a non-invasive therapeutic drug monitoring
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study population: patients with CSAI caused by MSSA | – | Other: Blood samples for the measurement of the concentration of cefazolin, Other: S. aureus culture isolate, Other: structured telephone interviewInpatients with CSAI caused by MSSA treated or intended to receive cefazolin within the next 24-48 hours (at least 10 (maximum of 20) critically-ill patients, at least 10 (maximum of 20) patients with an estimated glomerular filtration rate of <60ml/min, at least 10 patients with BSI). |
| Sub-study: Torque Teno virus (TTV) viremia | – | Other: Blood samples for the measurement of the concentration of cefazolin, Other: S. aureus culture isolate, Other: structured telephone interview, Other: Sub-study quantitative measurement of Torque Teno virusTTV viral load may indicate the immunological status of the host. The TTV sub-study is to to describe the viral kinetics of TTV in CSAI patients. |
| Sub-study: cefazolin concentrations in sweat | – | Other: Blood samples for the measurement of the concentration of cefazolin, Other: S. aureus culture isolate, Other: structured telephone interview, Other: Sub-study investigating cefazolin concentrations in sweatOut of the study population (patients with CSAI) a total of 15 CSAI patients will be included for the substudy investigating cefazolin concentrations in sweat as a non-invasive therapeutic drug monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with CSAI fulfilling the inclusion criteria and admitted at the University Hospital Basel.
Key inclusion criteria (2 listed)
- CSAI caused by MSSA. CSAI is defined as MSSA BSI with a positive follow-up blood culture result for MSSA or the presence of a site of infection remote from the primary focus caused by hematogenous seeding (e.g. endocarditis, vertebral osteomyelitis) or extension of the infection beyond the primary focus (e.g. septic thrombophlebitis or abscess); or deep-seated infections caused by MSSA (e.g. osteoarticular infections, deepseated abscesses).
- Current or intended treatment with cefazolin
Key exclusion criteria (12 listed)
- Previous enrolment into the current study within 30 days
- Hemodialysis (patients on hemofiltration are eligible)
- Patients who are very likely to stop treatment with cefazolin in the next 48 hours as per treating physician (because of treatment failure, switch to oral medication, palliative care, allergy etc.) or who are very likely to be discharged in the next 48 hours as per treating physician.
- Outpatients
- Women who are pregnant (special pharmacokinetic)
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 |
|---|---|---|
| Blood samples for the measurement of the concentration of cefazolinBlood samples for the measurement of the concentration of cefazolin will be collected on the 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (usually within 4 weeks after inclusion; only in patients on outpatient continuous parenteral antibiotic treatment). | Other | Study population: patients with CSAI caused by MSSA, Sub-study: Torque Teno virus (TTV) viremia, Sub-study: cefazolin concentrations in sweat |
| S. aureus culture isolateThe S. aureus culture isolate will be subjected to exact cefazolin MIC determination and to measurement of the level of cefazolin tolerance. | Other | Study population: patients with CSAI caused by MSSA, Sub-study: Torque Teno virus (TTV) viremia, Sub-study: cefazolin concentrations in sweat |
| structured telephone interviewStructured telephone interview for Patient follow- up after 30 days | Other | Study population: patients with CSAI caused by MSSA, Sub-study: Torque Teno virus (TTV) viremia, Sub-study: cefazolin concentrations in sweat |
| Sub-study quantitative measurement of Torque Teno virusAn additional EDTA sample will be drawn for quantitative polymerase chain reaction (PCR) of TTV DNA and analyses of cytokines and other parameters of the activation state of the immune system. | Other | Sub-study: Torque Teno virus (TTV) viremia |
| Sub-study investigating cefazolin concentrations in sweatFor each visit of included patients, a sweat sample will be collected via a CE certified Macroduct Sweat Collector. Eccrine sweat glands of the lower forearms are stimulated by pilocarpine (a parasympathomimetic) as well as a local current for 5min. Sweat is subsequently collected by capillary containers during 30min and transferred to small tubes on dry ice. Sweat sample analysis is conducted using mass spectrometry. | Other | Sub-study: cefazolin concentrations in sweat |
Primary outcome
Trough concentration of cefazolin in plasma samples
Time frame: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Trough concentration of cefazolin measured in plasma samples
Total plasma concentrations of cefazolin in plasma samples
Time frame: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Total plasma concentrations of cefazolin in plasma samples
Free drug concentrations of cefazolin in plasma samples
Time frame: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Free drug concentrations of cefazolin in plasma samples
Trough concentration of cefazolin in sweat samples
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Trough concentration of cefazolin measured in sweat samples
Total sweat concentrations of cefazolin
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Total sweat concentrations of cefazolin
Free drug concentrations of cefazolin in sweat samples
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Free drug concentrations of cefazolin in sweat samples
Target attainment (100%fT>MIC)
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Antibiotic susceptibility of the isolated pathogens determined by the use of an Minimum inhibitory concentration (MIC) test strip. Target attainment (100%fT>MIC) will be calculated for each patient and for each day the patient was sampled. Target attainment is defined as a measured free trough plasma concentration of cefazolin above the measured exact MICs of the causative pathogens at all points of time sampled.
5 secondary outcomes
Pharmacological target attainment (100%fT>MIC) in infected tissue
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Attainment of an accepted threshold for toxicity (100%fT>10xMIC) in blood
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
Level of cefazolin tolerance of the isolated pathogen
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
TTV substudy: quantification of DNA
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
TTV substudy: quantification of cytokines
Time frame: 1st, 3rd,7th and 14th day of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)
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 29 Mar 2022.
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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.
Michael Osthoff, PD Dr. med. principal investigator
University Hospital Basel, Division of Internal Medicine
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 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 2 inclusion and 12 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 29 Mar 2022. 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?
Trough concentration of cefazolin in plasma samples (time frame: 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (within 4 weeks)). The study lists 7 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 29 Mar 2022.