VancomycinPhase 4NCT05823116
Continuous vs. Intermittent Infusion Vancomycin
A Phase 4 study testing Vancomycin Continuous Infusion and Vancomycin Intermittent Infusion in people with Vancomycin, run by Aaron Cook at 1 site in United States.
Trial summary
Hospitalized adult participants prescribed vancomycin by their treating physician will be randomized to receive vancomycin via continuous or intermittent infusion and measures of kidney function and injury will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin
- What is being tested?
- Vancomycin Continuous Infusion and Vancomycin Intermittent Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 15 Jun 2025
- Phase
- Phase 4
- 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
- ≥ 18 years of age
- Hospitalized at University of Kentucky on a medical service (internal medicine or medical intensive care)
- Prescribed ≥ 2 doses of vancomycin per treating physician
- Be able to provide written, informed consent, or have a legally authorized representative (LAR) responsible for their care able to provide written, informed consent.
Who cannot join
- Chronic kidney disease (documented or prior to admission estimated GFR (eGFR) <60 ml/min/1.73m2 using non-race-based creatinine GFR equation)
- End stage kidney disease
- Stage 1 or higher AKI per Kidney Disease: Improving Global Outcomes (KDIGO) classification (serum creatinine increase ≥ 0.3 mg/dl or 1.5-1.9 times baseline; urine output < 0.5 ml/kg/hr for 6-12 hours)
- Greater than 2 doses of vancomycin within the last 72 hours
- Allergy to iohexol
- Uroepithelial tumors
- Pregnancy
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Continuous vs. Intermittent Infusion Vancomycin: Effects on Measured GFR and Kidney Injury Biomarkers
Hospitalized adult participants prescribed vancomycin by their treating physician will be randomized to receive vancomycin via continuous or intermittent infusion and measures of kidney function and injury will be collected.
Read the detailed description
All study participants regardless of participation status will have been prescribed vancomycin by a treating physician and received a dose per institutional standard of care. Participants will be randomized 1:1 in permuted blocks of 2, 4, or 6 to receive subsequent doses via continuous or intermittent infusion. Participants randomized to intermittent infusion will receive doses per standard of care at infusion rates of 1 gram per hour in every 8,-12, or -24 hour intervals, while participants randomized to continuous infusion will receive a total daily dose infused over a period of 24 hours.
Vancomycin concentration will not exceed 5mg/ml and will be infused via central (preferred) or peripheral administration. In order to ensure consistent dosing between study arms, a precision dosing platform will be used by the PI and team to determine total daily doses to best target an AUC of 500 mg x hr/L (range 400-600 mg x hr/L). A single vancomycin concentration will be obtained the following day with Bayesian-guided area-under-the-curve (AUC) monitoring (with dosing adjusted if needed) to ensure vancomycin exposure remains similar between infusion strategies. Both the initiation and discontinuation of vancomycin, as well as any additional therapeutic drug monitoring, will remain at the discretion of the primary clinical team.
Glomerular filtration rate (GFR) will be measured on the day of enrollment and day 3 by the administration of 5 ml iohexol (300 mgI/ml) with iohexol plasma concentrations obtained 1 and 4 hours following administration of iohexol. This change in measured GFR between the infusion strategies is the primary outcome of the study. Plasma and urinary markers of kidney function and injury will be obtained the day of enrollment (Day 0) and subsequent days (Days 2-3). If the participant remains on vancomycin 120 hours following enrollment, measured glomerular filtration rate (mGFR) and biomarkers will be assessed again.
- Conditions
- Vancomycin
- Being tested
- Vancomycin Continuous Infusion, Vancomycin Intermittent Infusion
- Keywords
- Infusion, Adverse Effect, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin Continuous InfusionDrug
Also called Vancocin
A precision drug dosing platform will be used to determine the empiric dosing regimen and the dosing parameter targeted will be an area-under-the-curve (AUC) of 500 mg⸱hr/L (range 400-600 mg⸱hr/L). The total daily dose is infused over a period of 24 hours.
Vancomycin Intermittent InfusionDrug
Also called Vancocin
A precision drug dosing platform will be used to determine the empiric dosing regimen and the dosing parameter targeted will be an area-under-the-curve (AUC) of 500 mg⸱hr/L (range 400-600 mg⸱hr/L). The dose is infused at rates of 1 gram per hour in every 8, -12, or -24 hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin continuous infusion | Active comparator | Continuous infusion of Vancomycin Receives: Drug: Vancomycin Continuous Infusion |
| Vancomycin intermittent infusion | Active comparator | Intermittent infusion of vancomycin Receives: Drug: Vancomycin Intermittent Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured glomerular filtration rate (GFR)
measured via the administration of a small dose of iohexol followed by the collection of blood samples
Measured: Baseline (Day 0) and Day 3
Change in urinary Kidney Injury Molecule 1 (KIM-1)
Measured by urine ELISA test as the change score
Measured: Baseline (Day 0) and Day 3
Secondary outcomes (12)
Plasma cystatin C over time
Measured by urine ELISA test at baseline, 48-, and 72-hours following the first dose of vancomycin.
Additional measure at 120 hours if the patient is prescribed vancomycin for 120 hours or more.
Measured: Baseline up to 5 days
Urine Clusterin over time
Measured by urine ELISA test at baseline, 48-, and 72-hours following the first dose of vancomycin. Additional measure at 120 hours if the patient is prescribed vancomycin for 120 hours or more.
Measured: Baseline up to 5 days
Urine Osteopontin over time
Measured by urine ELISA test at baseline, 48-, and 72-hours following the first dose of vancomycin. Additional measure at 120 hours if the patient is prescribed vancomycin for 120 hours or more.
Measured: Baseline up to 5 days
Urine Kidney Injury Molecule-1 (KIM-1) over time
Measured by urine ELISA test test at baseline, 48-, and 72-hours following the first dose of vancomycin. Additional measure at 120 hours if the patient is prescribed vancomycin for 120 hours or more.
Measured: Baseline up to 5 days
Change in Urine Kidney Injury Molecule-1 (KIM-1)
Measured as the change score, only in the only in subset of patients prescribed 5 or more days of vancomycin
Measured: Baseline (Day 0) and Day 5
Vancomycin Area-Under-the-Curve (AUC) target attainment
Defined as range 400-600 mg*hr/L. AUC assessed using one concentration Bayesian estimates.
Measured: Day 1
Acute Kidney Injury (AKI) over time
Using serum creatinine and urine output components of Kidney Disease: Improving Global Outcome (KIDGO) classification
Measured: Daily up to 10 days
Phlebitis over time
Monitored per standard of care, using phlebitis scores of 0 (no clinical symptoms) to 4. Documented scores above 0 will be classified as phlebitis.
Measured: Daily up to 7 days
Infiltration over time
Monitored per standard of care, using infiltration scores of 0 (no clinical symptoms) to 4. Documented scores above 0 will be classified as infiltration.
Measured: Daily up to 7 days
Acute Kidney Disease
measured per Acute Disease Quality Initiative (ADQI) criteria in a subset of participants where AKI does not resolve by 7 days
Measured: Until hospital discharge, up to 17 days
Number of Participants with Major Adverse Kidney Events
Composite of death, requirement for kidney replacement therapy, or reduction of 25% from baseline estimated glomerular filtration rate.
Measured: Until hospital discharge, up to 17 days
Change in measured glomerular filtration rate (GFR)
measured via the administration of a small dose of iohexol followed by the collection of blood samples, only in the subset of patients receiving vancomycin for 5 days
Measured: Baseline (Day 0) and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start22 May 2023
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VancomycinStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Cook
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Cook, University of Kentucky
- Investigators
- Aaron M Cook, PharmD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823116
- Sponsor's protocol ID
- 83412
- Other IDs
- R21AI176298
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Continuous vs. Intermittent Infusion Vancomycin: Effects on Measured GFR and Kidney Injury Biomarkers
- ClinicalTrials.gov ID
- NCT05823116
- Acronym / sponsor ID
- 83412
- Conditions
- Vancomycin
- Keywords
- Infusion, Adverse Effect, Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aaron CookUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 21 Apr 2023 (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.
Hospitalized adult participants prescribed vancomycin by their treating physician will be randomized to receive vancomycin via continuous or intermittent infusion and measures of kidney function and injury will be collected.
Detailed description
All study participants regardless of participation status will have been prescribed vancomycin by a treating physician and received a dose per institutional standard of care. Participants will be randomized 1:1 in permuted blocks of 2, 4, or 6 to receive subsequent doses via continuous or intermittent infusion. Participants randomized to intermittent infusion will receive doses per standard of care at infusion rates of 1 gram per hour in every 8,-12, or -24 hour intervals, while participants randomized to continuous infusion will receive a total daily dose infused over a period of 24 hours.
Vancomycin concentration will not exceed 5mg/ml and will be infused via central (preferred) or peripheral administration. In order to ensure consistent dosing between study arms, a precision dosing platform will be used by the PI and team to determine total daily doses to best target an AUC of 500 mg x hr/L (range 400-600 mg x hr/L). A single vancomycin concentration will be obtained the following day with Bayesian-guided area-under-the-curve (AUC) monitoring (with dosing adjusted if needed) to ensure vancomycin exposure remains similar between infusion strategies. Both the initiation and discontinuation of vancomycin, as well as any additional therapeutic drug monitoring, will remain at the discretion of the primary clinical team.
Glomerular filtration rate (GFR) will be measured on the day of enrollment and day 3 by the administration of 5 ml iohexol (300 mgI/ml) with iohexol plasma concentrations obtained 1 and 4 hours following administration of iohexol. This change in measured GFR between the infusion strategies is the primary outcome of the study. Plasma and urinary markers of kidney function and injury will be obtained the day of enrollment (Day 0) and subsequent days (Days 2-3). If the participant remains on vancomycin 120 hours following enrollment, measured glomerular filtration rate (mGFR) and biomarkers will be assessed again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin continuous infusion | Active comparator | Drug: Vancomycin Continuous InfusionContinuous infusion of Vancomycin |
| Vancomycin intermittent infusion | Active comparator | Drug: Vancomycin Intermittent InfusionIntermittent infusion of vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Hospitalized at University of Kentucky on a medical service (internal medicine or medical intensive care)
- Prescribed ≥ 2 doses of vancomycin per treating physician
- Be able to provide written, informed consent, or have a legally authorized representative (LAR) responsible for their care able to provide written, informed consent.
Key exclusion criteria (8 listed)
- Chronic kidney disease (documented or prior to admission estimated GFR (eGFR) <60 ml/min/1.73m2 using non-race-based creatinine GFR equation)
- End stage kidney disease
- Stage 1 or higher AKI per Kidney Disease: Improving Global Outcomes (KDIGO) classification (serum creatinine increase ≥ 0.3 mg/dl or 1.5-1.9 times baseline; urine output < 0.5 ml/kg/hr for 6-12 hours)
- Greater than 2 doses of vancomycin within the last 72 hours
- Allergy to iohexol
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 |
|---|---|---|
| Vancomycin Continuous InfusionAlso: VancocinA precision drug dosing platform will be used to determine the empiric dosing regimen and the dosing parameter targeted will be an area-under-the-curve (AUC) of 500 mg⸱hr/L (range 400-600 mg⸱hr/L). The total daily dose is infused over a period of 24 hours. | Drug | Vancomycin continuous infusion |
| Vancomycin Intermittent InfusionAlso: VancocinA precision drug dosing platform will be used to determine the empiric dosing regimen and the dosing parameter targeted will be an area-under-the-curve (AUC) of 500 mg⸱hr/L (range 400-600 mg⸱hr/L). The dose is infused at rates of 1 gram per hour in every 8, -12, or -24 hour intervals. | Drug | Vancomycin intermittent infusion |
Primary outcome
Change in measured glomerular filtration rate (GFR)
Time frame: Baseline (Day 0) and Day 3
measured via the administration of a small dose of iohexol followed by the collection of blood samples
Change in urinary Kidney Injury Molecule 1 (KIM-1)
Time frame: Baseline (Day 0) and Day 3
Measured by urine ELISA test as the change score
12 secondary outcomes
Plasma cystatin C over time
Time frame: Baseline up to 5 days
Urine Clusterin over time
Time frame: Baseline up to 5 days
Urine Osteopontin over time
Time frame: Baseline up to 5 days
Urine Kidney Injury Molecule-1 (KIM-1) over time
Time frame: Baseline up to 5 days
Change in Urine Kidney Injury Molecule-1 (KIM-1)
Time frame: Baseline (Day 0) and Day 5
Vancomycin Area-Under-the-Curve (AUC) target attainment
Time frame: Day 1
Acute Kidney Injury (AKI) over time
Time frame: Daily up to 10 days
Phlebitis over time
Time frame: Daily up to 7 days
Infiltration over time
Time frame: Daily up to 7 days
Acute Kidney Disease
Time frame: Until hospital discharge, up to 17 days
Number of Participants with Major Adverse Kidney Events
Time frame: Until hospital discharge, up to 17 days
Change in measured glomerular filtration rate (GFR)
Time frame: Baseline (Day 0) and Day 5
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 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Vancomycin
Active, not recruitingPhase 1/2
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Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
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RecruitingPhase 4
The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)
Infection, Acute Kidney Injury
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
RecruitingPhase 2
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC)
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.
Aaron M Cook, PharmD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin Continuous Infusion and Vancomycin Intermittent Infusion in people with Vancomycin, run by Aaron Cook at 1 site in United States.
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 8 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 15 Dec 2025. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in measured glomerular filtration rate (GFR) (time frame: Baseline (Day 0) and Day 3). The study lists 2 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 15 Dec 2025.