Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04648696

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the safety and outcomes associated between the two treatment modalities

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Vancomycin CI Drug: Vancomycin II	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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) settingTo 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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 3, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Nephrotoxicity [week 8]
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

Secondary Outcome Measures

Incidence of Leukopenia [week 8]
White Blood Cell (WBC) < 4,000 x 103 cells/µL
Number of Infusion-related reactions [week 8]
Flushing/Erythema /Rash/Red Man Syndrome
Number of serum vancomycin measurements within therapeutic range [week 8]
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
Number of Participants with Resolutions of symptoms associated with the infection [week 8]
No need for additional induction therapy beyond the planned end date
Number of Participants with Treatment Failures [week 21]
Persistence, new onset, or worsening local or systemic signs and symptoms of infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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