Continuous vs. Intermittent Infusion Vancomycin

NCT05823116 | Completed Phase 4 FDA Drug

• 2 other identifiers: 83412R21AI176298
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Vancomycin

Keywords

Infusion; Adverse Effect; Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Change in measured glomerular filtration rate (GFR)

  measured via the administration of a small dose of iohexol followed by the collection of blood samples

  Baseline (Day 0) and Day 3

• Change in urinary Kidney Injury Molecule 1 (KIM-1)

  Measured by urine ELISA test as the change score

  Baseline (Day 0) and Day 3

Secondary Outcomes (12)

• Plasma cystatin C over time

  Baseline up to 5 days

• Urine Clusterin over time

  Baseline up to 5 days

• Urine Osteopontin over time

  Baseline up to 5 days

• Urine Kidney Injury Molecule-1 (KIM-1) over time

  Baseline up to 5 days

• Change in Urine Kidney Injury Molecule-1 (KIM-1)

  Baseline (Day 0) and Day 5

Study Arms (2)

Vancomycin continuous infusion

ACTIVE COMPARATOR

Continuous infusion of Vancomycin

Drug: Vancomycin Continuous Infusion

Vancomycin intermittent infusion

ACTIVE COMPARATOR

Intermittent infusion of vancomycin

Drug: Vancomycin Intermittent Infusion

Interventions

Vancomycin Continuous Infusion 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.

Also known as: Vancocin

Vancomycin continuous infusion

Vancomycin Intermittent Infusion 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.

Also known as: Vancocin

Vancomycin intermittent infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Aaron Cook: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Aaron M Cook, PharmD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 21, 2023
• Study Start: May 22, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)