Methicillin-resistant Staphylococcus AureusPhase 1NCT02945241
Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project
A Phase 1 study testing Vancomycin, Cystatin C dosing algorithm and Creatine clearance dosing algorithm in people with Methicillin-resistant Staphylococcus Aureus and Sepsis, run by Mayo Clinic.
Trial summary
Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus, Sepsis, Critical Illness
- What is being tested?
- Vancomycin, Cystatin C dosing algorithm and Creatine clearance dosing algorithm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Mar 2016
- Phase
- Phase 1
- 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
Who may be able to join
- Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota
- Suspected or documented gram-positive infection
- Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval
Who cannot join
- Vulnerable population
- Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission
- Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute
- Undergoing renal replacement therapy
- Body mass index > 40kg/m2
- Weight < 40kg
About this study
Official title: Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults
Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.
Read the detailed description
This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.
- Being tested
- Vancomycin, Cystatin C dosing algorithm, Creatine clearance dosing algorithm
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancocin
Intravenous
Cystatin C dosing algorithmOther
Expressed in milliliters per minute
Creatine clearance dosing algorithmOther
Also called Cockcroft-Gault
Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute
| Study group | Role | What they receive |
|---|---|---|
| Cystatin C-guided vancomycin dosing algorithm | Experimental | Cystatin C is an endogenous cysteine proteinase inhibitor produced by all nucleated cells and a biomarker used routinely to estimate glomerular filtration rate either alone or in combination with creatinine. This new dosing algorithm includes patient weight, individualized goal trough concentration, and glomerular filtration rate (expressed with the CKD-EPI creatinine-cystatin C equation in mL/min) to determine dose and frequency. Receives: Drug: Vancomycin; Other: Cystatin C dosing algorithm |
| Creatinine clearance guided vancomycin dosing | Other | Historical controls for the quality improvement project had doses based on weight and interval established with the creatinine clearance using the Cockcroft-Gault equation. Receives: Drug: Vancomycin; Other: Creatine clearance dosing algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancomycin target trough achievement
The percentage of initial steady state troughs within the target range.
Measured: Baseline
Secondary outcomes (4)
Length of stay (hospital and ICU)
Measured: Baseline
Acute kidney injury (AKI) and renal replacement therapy
New onset AKI, defined as KDIGO stage II or greater AKI, within 48-hours of and within 7-days of vancomycin initiation
Measured: 7-days
Treatment failure
Treatment failure in patients with confirmed gram-positive infection after at least 48-hours of vancomycin therapy and within 7-days
Measured: 7-days
Infection recurrence
New onset of infection within 28-days among patients with confirmed gram-positive infection
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin Frazee, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945241
- Sponsor's protocol ID
- 14-002808
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2016
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Frazee EN, Rule AD, Herrmann SM, Kashani KB, Leung N, Virk A, Voskoboev N, Lieske JC. Serum cystatin C predicts vancomycin trough levels better than serum creatinine in hospitalized patients: a cohort study. Crit Care. 2014 May 29;18(3):R110. doi: 10.1186/cc13899.
PubMed 24887089
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT02945241
- Acronym / sponsor ID
- 14-002808
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.
Detailed description
This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystatin C-guided vancomycin dosing algorithm | Experimental | Drug: Vancomycin, Other: Cystatin C dosing algorithmCystatin C is an endogenous cysteine proteinase inhibitor produced by all nucleated cells and a biomarker used routinely to estimate glomerular filtration rate either alone or in combination with creatinine. This new dosing algorithm includes patient weight, individualized goal trough concentration, and glomerular filtration rate (expressed with the CKD-EPI creatinine-cystatin C equation in mL/min) to determine dose and frequency. |
| Creatinine clearance guided vancomycin dosing | Other | Drug: Vancomycin, Other: Creatine clearance dosing algorithmHistorical controls for the quality improvement project had doses based on weight and interval established with the creatinine clearance using the Cockcroft-Gault equation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota
- Suspected or documented gram-positive infection
- Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval
Key exclusion criteria (6 listed)
- Vulnerable population
- Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission
- Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute
- Undergoing renal replacement therapy
- Body mass index > 40kg/m2
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 |
|---|---|---|
| VancomycinAlso: VancocinIntravenous | Drug | Creatinine clearance guided vancomycin dosing, Cystatin C-guided vancomycin dosing algorithm |
| Cystatin C dosing algorithmExpressed in milliliters per minute | Other | Cystatin C-guided vancomycin dosing algorithm |
| Creatine clearance dosing algorithmAlso: Cockcroft-GaultVancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute | Other | Creatinine clearance guided vancomycin dosing |
Primary outcome
Vancomycin target trough achievement
Time frame: Baseline
The percentage of initial steady state troughs within the target range.
4 secondary outcomes
Length of stay (hospital and ICU)
Time frame: Baseline
Acute kidney injury (AKI) and renal replacement therapy
Time frame: 7-days
Treatment failure
Time frame: 7-days
Infection recurrence
Time frame: 28-days
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 10 Oct 2023.
- Background: PubMed 24887089Frazee EN, Rule AD, Herrmann SM, Kashani KB, Leung N, Virk A, Voskoboev N, Lieske JC. Serum cystatin C predicts vancomycin trough levels better than serum creatinine in hospitalized patients: a cohort study. Crit Care. 2014 May 29;18(3):R110. doi: 10.1186/cc13899.
- 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.
Erin Frazee, PharmD, RPh principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin, Cystatin C dosing algorithm and Creatine clearance dosing algorithm in people with Methicillin-resistant Staphylococcus Aureus and Sepsis, run by Mayo Clinic.
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 3 inclusion and 6 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vancomycin target trough achievement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945241, which also lists 1 linked publication.
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 10 Oct 2023.