Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Study Overview
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Brief Summary
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Evaluate the safety and outcomes associated between the two treatment modalities

Detailed Description
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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

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

Conditions
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Infection

Intervention / Treatment
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* Drug: Vancomycin CI
* Drug: Vancomycin II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients at least 18 years of age Receiving Wake Forest Baptist Health 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: WBC < 4,000 x 103 cells/µL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nephrotoxicity | 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 |
| --- | --- | --- |
| Incidence of Leukopenia | 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 | CI goal - area under the curve (AUC)/minimum inhibitory concentration (MIC)400 - 600 mg x hr/L (a vancomycin random within 16.7 and 25.0 mcg/mL will correlate with this range) II goal - 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 | No need for additional induction therapy beyond the planned end date | week 8 | 
| Number of Participants with Treatment Failures | Persistence, new onset, or worsening local or systemic signs and symptoms of infection | week 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infusion therapy, continuous infusions, nephrotoxicity, outpatient parenteral antibiotic therapy, vancomycin