Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial

Evaluate the safety and outcomes associated between the two treatment modalities

Study Overview

• Status: Terminated
• Conditions: Infection
• Intervention / Treatment: Drug: Vancomycin CI; Drug: Vancomycin II

Detailed Description

Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients at least 18 years of age
• Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
• Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
• Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
• Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment

Exclusion Criteria:

• Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
• Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continuous infusions (CI) group; CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge	Drug: Vancomycin CI; The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin; Other Names: glycopeptide antibiotic
Active Comparator: Intermittent infusion (II) group; Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge	Drug: Vancomycin II; Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge; Other Names: glycopeptide antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Nephrotoxicity in Subjects	Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Leukopenia in Subjects	Number of Subjects with White Blood Cell (WBC) < 4,000 x 103 cells/µL	week 8
Number of Infusion-related Reactions	Flushing/Erythema /Rash/Red Man Syndrome	week 8
Number of Serum Vancomycin Measurements Within Therapeutic Range	Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL	week 8
Number of Participants With Resolutions of Symptoms Associated With the Infection	Number of Subjects without need for additional induction therapy beyond the planned end date	week 8
Number of Participants With Treatment Failures	Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection	week 21

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: John Williamson, PharmD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: nephrotoxicity; vancomycin; infusion therapy; continuous infusions; outpatient parenteral antibiotic therapy
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antitubercular Agents; Vancomycin; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: IRB00069815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No