Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Phase 4TerminatedNCT04648696

Wake Forest University Health Sciences8 enrolled

Overview

Evaluate the safety and outcomes associated between the two treatment modalities

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection

Interventions

Vancomycin CIDRUG

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

Vancomycin IIDRUG

Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: week 8

Secondary Outcomes

Number of Leukopenia in Subjects

Number of Subjects with White Blood Cell (WBC) \< 4,000 x 103 cells/µL

Time frame: week 8

Number of Infusion-related Reactions

Flushing/Erythema /Rash/Red Man Syndrome

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: week 21

Data from ClinicalTrials.gov

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