Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Infection

Treatments: Drug: Vancomycin CI; Drug: Vancomycin II

Study type: Interventional

Funder types: Other

Identifiers

NCT04648696

IRB00069815

Details and patient eligibility

About

Evaluate the safety and outcomes associated between the two treatment modalities

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

continuous infusions (CI) group

Active Comparator group

Description:

CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge

Treatment:

Drug: Vancomycin CI

Intermittent infusion (II) group

Active Comparator group

Description:

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

Treatment:

Drug: Vancomycin II