Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)Phase 2TARGET IIINCT05655091
Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
A Phase 2 study testing FLU or CZO as continuous infusion and standard FLU or CZO intermittent bolus administration in people with Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
- What is being tested?
- FLU or CZO as continuous infusion and standard FLU or CZO intermittent bolus administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Informed Consent as documented by signature. For patients, who are not able to sign consent, a physician not involved in the current study has to confirm that patient's interest and rights are guaranteed during participation in the current study. Subsequently, informed consent will be obtained as soon as possible from the patient or his/her legally authorised representative.
- Age ≥ 18 years
- CSAI which is defined as (i) blood stream infection (BSI) with S. aureus or (ii) deep-seated infections caused by S. aureus (e.g. osteoarticular infections, deep-seated abscesses) without BSI.
- Intended or active (less than 24 hours) treatment with FLU or CZO
Who cannot join
- Patients on hemodialysis or eGFR<10 ml/min as these patients have a special pharmacokinetic
- Patients on Cytosorb® therapy
- Patients with liver cirrhosis CHILD B and C
- Patients who are very likely to stop treatment with FLU or CZO 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 or transferred to another hospital in the next 48 hours as per treating physician.
- Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Cutibacterium acnes). If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
- CSAI caused by methicillin-resistant S. aureus (MRSA)
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- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Division of Internal Medicine
Basel, 4031
Michael Osthoff, PD Dr. med., +41 61 328 54 20, michael.osthoff@usb.ch
Sarah Dräger, Dr. med., +41 61 328 77 11, sarah.draeger@usb.ch
About this study
Official title: Can Continuous Infusion Coupled With Therapeutic Drug Monitoring Optimize Flucloxacillin and Cefazolin Target Attainment Compared to Standard Intermittent Bolus Dosing in Patients With Complicated Staphylococcus Aureus Infections? A Randomized, Controlled Interventional Pilot Trial.
This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".
Read the detailed description
Therapeutic drug monitoring (TDM) has recently been established as one of the cornerstones to individualize treatment of β-lactam antibiotics. It is particularly useful in patients hospitalized in the intensive care unit (ICU) being at risk to not achieve optimal antibiotic plasma concentrations due to a strongly altered metabolism. Along the same lines, continuous administration of β-lactam antibiotics instead of standard intermittent bolus administration may maintain drug concentrations in the target range throughout the dosing interval, and even contribute to a decrease in mortality. This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all". The primary objective of this trial is to evaluate the achievement of the optimal pharmacological target concentration (100% fT 2 to 12 mg/L) in blood on day 3 after inclusion with continuous infusion FLU and CZO in combination with real-time TDM and subsequent dose adjustment, versus the current standard of care in patients with CSAI, and to estimate the effect size for future trials. To evaluate the PKPD of unbound FLU or CZO in the intervention versus the control group as measured by the following:
- Drug concentration at second or later TDM including the incidence of high (e.g. 100% fT>12 mg/L) and low concentrations (e.g. 100% fT<2mg/L)
- Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity)
- Time to optimal target attainment and percentage of days with optimal target attainment in relation to total study drug treatment duration
- Intra-individual variability in FLU und CZO total and unbound plasma concentrations
- Factors associated with pharmacological target attainment (e.g. kidney function, protein, albumin, age, sex, weight, concomitant medication)
Sub-study I:
- Evaluation of the pharmacological profile of penicillin in patients in whom treatment was changed from FLU or CZO to penicillin due to a penicillin susceptible S. aureus strain.
Sub-study II:
- Assessment of patient satisfaction, rest-activity rhythms and sleep quality by actigraphy, sleep diaries and questionnaire in patients admitted to a general ward.
Patients will be randomized in two parallel groups stratified to the use of FLU or CZO in a 1:1 ratio to be treated either by continuous infusion plus TDM and dose adjustment or by standard intermittent bolus application.
Drug concentrations will be measured at day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge. After discharge, TDM will be performed 1x/week if the patient is treated in the outpatient parenteral antibiotic treatment (OPAT) program but without any dose adjustments. Dose adjustments of FLU and CZO in the intervention group will be performed according to a pharmacokinetic modelling application that is based on the data of our previous studies TARGET [2] and TARGET II (unpublished data). In the control group, blood samples will be drawn and analysed directly, but the results will not be communicated to the study team or a physician involved in the treatment of the patient. No TDM-guided dose adjustment will be performed in the control group
- Being tested
- FLU or CZO as continuous infusion, standard FLU or CZO intermittent bolus administration
- Keywords
- Therapeutic drug monitoring (TDM), Flucloxacillin (FLU), Cefazolin (CZO), β-lactam antibiotics, antibiotic plasma concentration, standard intermittent bolus administration, continuous infusion, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLU or CZO as continuous infusionDrug
Continuous infusion FLU or CZO coupled with real-time TDM and subsequent dose adjustment. A loading dose will be administered prior to the first continuous infusion. The loading dose (maximum of 2g as licensed according to the SmPC) and the dose of the continuous infusion will be calculated according to a pharmacokinetic model taking into account patient's characteristics (e.g. age, sex) and the measured drug concentration. The maximum daily dose of FLU and CZO will not exceed 12 grams per day according to the SmPC.
standard FLU or CZO intermittent bolus administrationDrug
Standard FLU or CZO intermittent bolus administration according to the local guidelines adjusted to the renal function without TDM-guided dose adjustment.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Subjects randomized into the intervention group will receive FLU or CZO respectively as continuous infusion as soon as targeted S. aureus treatment is initiated (+24h). The choice of antibiotic is determined by the treating physician in accordance to the recommendations of the infectious diseases (ID) specialists. The loading dose and dose adjustments of FLU and CZO will be determined by the use of a pharmacokinetic modelling application. The maximum daily dose will not exceed the daily licensed dose according to the Summary of Product Characteristics (SmPC). Receives: Drug: FLU or CZO as continuous infusion |
| control group | Active comparator | Subjects randomized to the control group will receive standard of care intermittent bolus infusion FLU or CZO dosed according to the recommendations of the ID specialist and treating physician. Drug concentration will be analysed directly, but the results will not be communicated to the study team or a physician involved in the treatment of the patient. No TDM-guided dose adjustment will be performed in the control group. Receives: Drug: standard FLU or CZO intermittent bolus administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that attain the (FLU or CZO) target concentration (100% fT 2 to 12 mg/L) in blood.
For the assessment of the primary endpoint (100% fT 2 to 12 mg/L), the plasma concentration of FLU or CZO will be measured at day 3 after inclusion of the patient.
Measured: On day 3 after inclusion
Secondary outcomes (6)
Proportion of patients attaining the target (FLU or CZO) concentration at second TDM
Change in plasma concentration of FLU and CZO will be measured
Measured: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of high (e.g. 100% fT>12 mg/L) (FLU or CZO) concentrations
Incidence of high (e.g. 100% fT>12 mg/L) (FLU or CZO) concentrations
Measured: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of low concentrations (e.g. 100% fT<2mg/L) (FLU or CZO) concentrations
Incidence of low concentrations (e.g. 100% fT<2mg/L) (FLU or CZO) concentrations
Measured: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity)
Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity)
Measured: From Day 0 (enrolment) until discharge (up to 6 weeks)
Percentage of days with optimal target attainment in relation to total study treatment duration
Percentage of days with optimal target attainment in relation to total study treatment duration
Measured: From Day 0 (enrolment) until discharge (up to 6 weeks)
Intra-individual variability in FLU und CZO total and unbound plasma concentrations
Intra-individual variability in FLU und CZO measured by change in plasma concentrations (total and unbound)
Measured: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start26 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, randomised, controlled, interventional pilot trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- 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
- NCT05655091
- Sponsor's protocol ID
- 2022-01708; am21Osthoff
- Acronym
- TARGET III
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2022
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Continuous Infusion Coupled With Therapeutic Drug Monitoring Optimize Flucloxacillin and Cefazolin Target Attainment Compared to Standard Intermittent Bolus Dosing in Patients With Complicated Staphylococcus Aureus Infections? A Randomized, Controlled Interventional Pilot Trial.
- ClinicalTrials.gov ID
- NCT05655091
- Acronym / sponsor ID
- TARGET III / 2022-01708; am21Osthoff
- Keywords
- Therapeutic drug monitoring (TDM), Flucloxacillin (FLU), Cefazolin (CZO), β-lactam antibiotics, antibiotic plasma concentration, standard intermittent bolus administration, continuous infusion, Staphylococcus aureus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Dec 2022 (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 prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".
Detailed description
Therapeutic drug monitoring (TDM) has recently been established as one of the cornerstones to individualize treatment of β-lactam antibiotics. It is particularly useful in patients hospitalized in the intensive care unit (ICU) being at risk to not achieve optimal antibiotic plasma concentrations due to a strongly altered metabolism. Along the same lines, continuous administration of β-lactam antibiotics instead of standard intermittent bolus administration may maintain drug concentrations in the target range throughout the dosing interval, and even contribute to a decrease in mortality. This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all". The primary objective of this trial is to evaluate the achievement of the optimal pharmacological target concentration (100% fT 2 to 12 mg/L) in blood on day 3 after inclusion with continuous infusion FLU and CZO in combination with real-time TDM and subsequent dose adjustment, versus the current standard of care in patients with CSAI, and to estimate the effect size for future trials. To evaluate the PKPD of unbound FLU or CZO in the intervention versus the control group as measured by the following:
- Drug concentration at second or later TDM including the incidence of high (e.g. 100% fT>12 mg/L) and low concentrations (e.g. 100% fT<2mg/L)
- Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity)
- Time to optimal target attainment and percentage of days with optimal target attainment in relation to total study drug treatment duration
- Intra-individual variability in FLU und CZO total and unbound plasma concentrations
- Factors associated with pharmacological target attainment (e.g. kidney function, protein, albumin, age, sex, weight, concomitant medication)
Sub-study I:
- Evaluation of the pharmacological profile of penicillin in patients in whom treatment was changed from FLU or CZO to penicillin due to a penicillin susceptible S. aureus strain.
Sub-study II:
- Assessment of patient satisfaction, rest-activity rhythms and sleep quality by actigraphy, sleep diaries and questionnaire in patients admitted to a general ward.
Patients will be randomized in two parallel groups stratified to the use of FLU or CZO in a 1:1 ratio to be treated either by continuous infusion plus TDM and dose adjustment or by standard intermittent bolus application.
Drug concentrations will be measured at day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge. After discharge, TDM will be performed 1x/week if the patient is treated in the outpatient parenteral antibiotic treatment (OPAT) program but without any dose adjustments. Dose adjustments of FLU and CZO in the intervention group will be performed according to a pharmacokinetic modelling application that is based on the data of our previous studies TARGET [2] and TARGET II (unpublished data). In the control group, blood samples will be drawn and analysed directly, but the results will not be communicated to the study team or a physician involved in the treatment of the patient. No TDM-guided dose adjustment will be performed in the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre, randomised, controlled, interventional pilot trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: FLU or CZO as continuous infusionSubjects randomized into the intervention group will receive FLU or CZO respectively as continuous infusion as soon as targeted S. aureus treatment is initiated (+24h). The choice of antibiotic is determined by the treating physician in accordance to the recommendations of the infectious diseases (ID) specialists. The loading dose and dose adjustments of FLU and CZO will be determined by the use of a pharmacokinetic modelling application. The maximum daily dose will not exceed the daily licensed dose according to the Summary of Product Characteristics (SmPC). |
| control group | Active comparator | Drug: standard FLU or CZO intermittent bolus administrationSubjects randomized to the control group will receive standard of care intermittent bolus infusion FLU or CZO dosed according to the recommendations of the ID specialist and treating physician. Drug concentration will be analysed directly, but the results will not be communicated to the study team or a physician involved in the treatment of the patient. No TDM-guided dose adjustment will be performed in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent as documented by signature. For patients, who are not able to sign consent, a physician not involved in the current study has to confirm that patient's interest and rights are guaranteed during participation in the current study. Subsequently, informed consent will be obtained as soon as possible from the patient or his/her legally authorised representative.
- Age ≥ 18 years
- CSAI which is defined as (i) blood stream infection (BSI) with S. aureus or (ii) deep-seated infections caused by S. aureus (e.g. osteoarticular infections, deep-seated abscesses) without BSI.
- Intended or active (less than 24 hours) treatment with FLU or CZO
Key exclusion criteria (9 listed)
- Patients on hemodialysis or eGFR<10 ml/min as these patients have a special pharmacokinetic
- Patients on Cytosorb® therapy
- Patients with liver cirrhosis CHILD B and C
- Patients who are very likely to stop treatment with FLU or CZO 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 or transferred to another hospital in the next 48 hours as per treating physician.
- Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Cutibacterium acnes). If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
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 |
|---|---|---|
| FLU or CZO as continuous infusionContinuous infusion FLU or CZO coupled with real-time TDM and subsequent dose adjustment. A loading dose will be administered prior to the first continuous infusion. The loading dose (maximum of 2g as licensed according to the SmPC) and the dose of the continuous infusion will be calculated according to a pharmacokinetic model taking into account patient's characteristics (e.g. age, sex) and the measured drug concentration. The maximum daily dose of FLU and CZO will not exceed 12 grams per day according to the SmPC. | Drug | intervention group |
| standard FLU or CZO intermittent bolus administrationStandard FLU or CZO intermittent bolus administration according to the local guidelines adjusted to the renal function without TDM-guided dose adjustment. | Drug | control group |
Primary outcome
Proportion of patients that attain the (FLU or CZO) target concentration (100% fT 2 to 12 mg/L) in blood.
Time frame: On day 3 after inclusion
For the assessment of the primary endpoint (100% fT 2 to 12 mg/L), the plasma concentration of FLU or CZO will be measured at day 3 after inclusion of the patient.
6 secondary outcomes
Proportion of patients attaining the target (FLU or CZO) concentration at second TDM
Time frame: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of high (e.g. 100% fT>12 mg/L) (FLU or CZO) concentrations
Time frame: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of low concentrations (e.g. 100% fT<2mg/L) (FLU or CZO) concentrations
Time frame: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity)
Time frame: From Day 0 (enrolment) until discharge (up to 6 weeks)
Percentage of days with optimal target attainment in relation to total study treatment duration
Time frame: From Day 0 (enrolment) until discharge (up to 6 weeks)
Intra-individual variability in FLU und CZO total and unbound plasma concentrations
Time frame: At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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.
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?
A Phase 2 study testing FLU or CZO as continuous infusion and standard FLU or CZO intermittent bolus administration in people with Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI), 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Osthoff, PD Dr. med. (+41 61 328 54 20, michael.osthoff@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that attain the (FLU or CZO) target concentration (100% fT 2 to 12 mg/L) in blood. (time frame: On day 3 after inclusion). 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 16 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.