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Anti-infective
Continuous vs Intermittent Vancomycin Infusion for Infections
Phase 4
Recruiting
Led By Alexander H Flannery, PharmD, PhD
Research Sponsored by Alexander Flannery
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
Study Summary
This trial will look at if continuous or intermittent vancomycin is better for adults in hospital, with tests of kidney function.
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.Check my eligibility
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in urinary Kidney Injury Molecule 1 (KIM-1)
Secondary outcome measures
Acute Kidney Disease
Acute Kidney Injury (AKI) over time
Change in Urine Kidney Injury Molecule-1 (KIM-1)
+9 moreTrial 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
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Who is running the clinical trial?
Alexander FlanneryLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,181 Total Patients Enrolled
Alexander H Flannery, PharmD, PhDPrincipal InvestigatorUniversity of Kentucky
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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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the federal regulatory agency given permission for Vancomycin continuous infusion?
"Our team has evaluated the safety of Vancomycin continuous infusion as a 3, which is reflective of its Phase 4 status indicating that it has already been approved."
Answered by AI
Are there any available positions in this clinical trial currently?
"As indicated by clinicaltrials.gov, the recruitment phase for this medical study has concluded as of April 6th 2023. Despite that, there are still 4 other trials open to applicants at present."
Answered by AI
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