Kidney Failure, ChronicNCT03909698
Antibiotic Dosing in Patients on Intermittent Hemodialysis
An observational study of Kidney Failure, Chronic and Antibiotics, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Antibiotics, Hemodialysis
- What is being tested?
- Blood and urine sampling
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2016to 31 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: Per antibiotic agent, up to 30 patients are included. The final needed number is anticipated by the numer of smamples per patient and the pharmacokinetic modeling.
Who may be able to join
- patients with end-stage kidney disease, requiring intermittent hemodialysis
- patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim)
Who cannot join
- pregnant woman
- absence of written informed consent from the patient
- known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.
- Conditions
- Kidney Failure, Chronic, Antibiotics, Hemodialysis
- Being tested
- Blood and urine sampling
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplingOther
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients on amoxicillin-clavulanic acid | The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings.
All blood and urine samples are analyzed for amoxicillin-clavulanic acid. Receives: Other: Blood and urine sampling | |
| Hemodialysis patients on ceftazidim | The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings.
All blood and urine samples are analyzed for ceftazidim. Receives: Other: Blood and urine sampling | |
| Hemodialysis patients on piperacillin-tazobactam | The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings.
All blood and urine samples are analyzed for piperacillin-tazobactam. Receives: Other: Blood and urine sampling | |
| Hemodialysis patients on vancomycin | The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings.
All blood and urine samples are analyzed for vancomycin. Receives: Other: Blood and urine sampling | |
| Hemodialysis patients on teicoplanin | The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings.
All blood and urine samples are analyzed for teicoplanin. Receives: Other: Blood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
Measured free and total concentration of the glycopeptide vancomycin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=400 for vancomycin.
Measured: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin
Measured free and total concentration of the glycopeptide teicoplanin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=750 for teicoplanin.
Measured: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid
Measured concentration of the beta-lactam amoxicillin-clavulanic acid is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Measured: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam
Measured concentration of the beta-lactam piperacillin-tazobactam is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Measured: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim
Measured concentration of the beta-lactam ceftazidim is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets:
minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Measured: 9/2016 - 12/2021
Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured vancomycin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured vancomycin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Measured: 9/2016 - 12/2021
Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured teicoplanin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured teicoplanin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Measured: 9/2016 - 12/2021
Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured amoxicillin-clavulanic acid concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured amoxicillin-clavulanic acid concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Measured: 9/2016 - 12/2021
Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured piperacillin-tazobactam concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured piperacillin-tazobactam concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Measured: 9/2016 - 12/2021
Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured ceftazidim concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured ceftazidim concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Measured: 9/2016 - 12/2021
Secondary outcomes (5)
Dialyser extraction rate of vancomycin
From dialyser inlet and outlet samples, the extraction ratio is calculated for vancomycin and entered in the kinetic analysis
Measured: 9/2016 - 12/2021
Dialyser extraction rate of teicoplanin
From dialyser inlet and outlet samples, the extraction ratio is calculated for teicoplanin and entered in the kinetic analysis
Measured: 9/2016 - 12/2021
Dialyser extraction rate of amoxicillin-clavulanic acid
From dialyser inlet and outlet samples, the extraction ratio is calculated for amoxicillin-clavulanic acid and entered in the kinetic analysis
Measured: 9/2016 - 12/2021
Dialyser extraction rate of piperacillin-tazobactam
From dialyser inlet and outlet samples, the extraction ratio is calculated for piperacillin-tazobactam and entered in the kinetic analysis
Measured: 9/2016 - 12/2021
Dialyser extraction rate of ceftazidim
From dialyser inlet and outlet samples, the extraction ratio is calculated for ceftazidim and entered in the kinetic analysis
Measured: 9/2016 - 12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start15 Sep 2016
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Wim Van Biesen, PhD, MD, Study chair, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909698
- Sponsor's protocol ID
- UGent_ABdosing
- Status last verified
- Aug 2021
- First submitted
- 4 Apr 2019
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Dosing in Patients on Intermittent Hemodialysis
- ClinicalTrials.gov ID
- NCT03909698
- Acronym / sponsor ID
- UGent_ABdosing
- Conditions
- Kidney Failure, Chronic, Antibiotics, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Apr 2019 (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.
The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients on amoxicillin-clavulanic acid | – | Other: Blood and urine samplingThe antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for amoxicillin-clavulanic acid. |
| Hemodialysis patients on ceftazidim | – | Other: Blood and urine samplingThe antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for ceftazidim. |
| Hemodialysis patients on piperacillin-tazobactam | – | Other: Blood and urine samplingThe antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for piperacillin-tazobactam. |
| Hemodialysis patients on vancomycin | – | Other: Blood and urine samplingThe antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for vancomycin. |
| Hemodialysis patients on teicoplanin | – | Other: Blood and urine samplingThe antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for teicoplanin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Per antibiotic agent, up to 30 patients are included. The final needed number is anticipated by the numer of smamples per patient and the pharmacokinetic modeling.
Key inclusion criteria (2 listed)
- patients with end-stage kidney disease, requiring intermittent hemodialysis
- patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim)
Key exclusion criteria (3 listed)
- pregnant woman
- absence of written informed consent from the patient
- known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics
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 and urine samplingDuring a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals. | Other | Hemodialysis patients on amoxicillin-clavulanic acid, Hemodialysis patients on ceftazidim, Hemodialysis patients on piperacillin-tazobactam, Hemodialysis patients on teicoplanin, Hemodialysis patients on vancomycin |
Primary outcome
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
Time frame: 9/2016 - 12/2021
Measured free and total concentration of the glycopeptide vancomycin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=400 for vancomycin.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin
Time frame: 9/2016 - 12/2021
Measured free and total concentration of the glycopeptide teicoplanin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be >=750 for teicoplanin.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid
Time frame: 9/2016 - 12/2021
Measured concentration of the beta-lactam amoxicillin-clavulanic acid is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam
Time frame: 9/2016 - 12/2021
Measured concentration of the beta-lactam piperacillin-tazobactam is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim
Time frame: 9/2016 - 12/2021
Measured concentration of the beta-lactam ceftazidim is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis
Time frame: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured vancomycin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured vancomycin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis
Time frame: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured teicoplanin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured teicoplanin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis
Time frame: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured amoxicillin-clavulanic acid concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured amoxicillin-clavulanic acid concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis
Time frame: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured piperacillin-tazobactam concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured piperacillin-tazobactam concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis
Time frame: 9/2016 - 12/2021
Population pharmacokinetic modeling is performed based on the measured ceftazidim concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured ceftazidim concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
5 secondary outcomes
Dialyser extraction rate of vancomycin
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of teicoplanin
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of amoxicillin-clavulanic acid
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of piperacillin-tazobactam
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of ceftazidim
Time frame: 9/2016 - 12/2021
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 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Wim Van Biesen, PhD, MD study chair
University Hospital, Ghent
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 Kidney Failure, Chronic and Antibiotics, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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 Nov 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 Belgium. 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?
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin (time frame: 9/2016 - 12/2021). The study lists 10 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 Nov 2022.