Continuous vs. Intermittent Infusion Vancomycin

NCT ID: NCT05823116

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-06-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vancomycin continuous infusion

Continuous infusion of Vancomycin

Group Type: ACTIVE_COMPARATOR

Vancomycin Continuous Infusion

Intervention Type: DRUG

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 infusion

Intermittent infusion of vancomycin

Group Type: ACTIVE_COMPARATOR

Vancomycin Intermittent Infusion

Intervention Type: DRUG

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.

Interventions

Vancomycin Continuous Infusion

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.

Intervention Type: DRUG

Vancomycin Intermittent Infusion

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.

Intervention Type: DRUG

Other Intervention Names

Vancocin; Vancocin

Eligibility Criteria

Inclusion Criteria

• ≥ 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Aaron Cook

OTHER

Sponsor Role: lead

Responsible Party

Aaron Cook

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aaron M Cook, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AI176298

Identifier Type: NIH

Identifier Source: secondary_id

View Link

83412

Identifier Type: -

Identifier Source: org_study_id