Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-10-31

Brief Summary

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Evaluate the safety and outcomes associated between the two treatment modalities

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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

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous infusions (CI) group

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

Group Type ACTIVE_COMPARATOR

Vancomycin CI

Intervention Type DRUG

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

Intermittent infusion (II) group

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

Group Type ACTIVE_COMPARATOR

Vancomycin II

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Vancomycin II

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

Intervention Type DRUG

Other Intervention Names

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glycopeptide antibiotic glycopeptide antibiotic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No