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Anti-infective
Continuous vs Intermittent Vancomycin Infusion for Infections
Lexington, KY
Phase 4
Recruiting
Led By Alexander H Flannery, PharmD, PhD
Research Sponsored by Aaron Cook
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until hospital discharge, up to 17 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will look at if continuous or intermittent vancomycin is better for adults in hospital, with tests of kidney function.
See full description
Who is the study for?
This trial is for hospitalized adults at the University of Kentucky who need vancomycin treatment, are over 18 years old, and can give consent. It's not for those with chronic kidney disease, recent acute kidney injury, prior vancomycin use within 72 hours (except loading dose), allergy to iohexol, uroepithelial tumors, prisoners, pregnant women or individuals with end-stage kidney disease.
What is being tested?
The study compares two ways of giving vancomycin: a continuous infusion versus an intermittent infusion. Participants will be randomly assigned to one method and their kidney function will be monitored to see which method is safer and more effective.See study design
What are the potential side effects?
Vancomycin may cause side effects like kidney damage (nephrotoxicity), allergic reactions including rash or fever, hearing problems if used long-term or in high doses, and rarely blood disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until hospital discharge, up to 17 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until hospital discharge, up to 17 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in urinary Kidney Injury Molecule 1 (KIM-1)
Secondary study objectives
Acute Kidney Disease
Acute Kidney Injury (AKI) over time
Change in Urine Kidney Injury Molecule-1 (KIM-1)
+9 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Vancomycin continuous infusionActive Control1 Intervention
Continuous infusion of Vancomycin
Group II: Vancomycin intermittent infusionActive Control1 Intervention
Intermittent infusion of vancomycin
Find a Location
Closest Location:University of Kentucky· Lexington, KY
Who is running the clinical trial?
Aaron CookLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Alexander FlanneryLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,359 Previous Clinical Trials
5,515,032 Total Patients Enrolled
Alexander H Flannery, PharmD, PhDPrincipal InvestigatorUniversity of Kentucky
Aaron M Cook, PharmDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has prescribed me two or more doses of vancomycin.I have chronic kidney disease with a GFR under 60.My kidneys are in the final stage of failure.I have a bladder cancer.I can sign or have someone legally allowed to sign for me.I have taken vancomycin in the last 72 hours.I am 18 years old or older.My kidney function has recently worsened.
Research Study Groups:
This trial has the following groups:- Group 1: Vancomycin continuous infusion
- Group 2: Vancomycin intermittent infusion
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.