Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Phase 4

Terminated

• Conditions: Infection
• Interventions: Drug: Vancomycin CI; Drug: Vancomycin II

• Registration Number: NCT04648696
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Evaluate the safety and outcomes associated between the two treatment modalities

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-03-03
• Status Verified: 2022-09
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Results First Submitted: 2023-11-30
• Results First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Results First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous infusions (CI) group	Vancomycin CI	CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Intermittent infusion (II) group	Vancomycin II	Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge

Primary Outcome Measures

Name	Time	Method
Number of Nephrotoxicity in Subjects	week 8	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

Secondary Outcome Measures

Name	Time	Method
Number of Leukopenia in Subjects	week 8	Number of Subjects with 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	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
Number of Participants With Resolutions of Symptoms Associated With the Infection	week 8	Number of Subjects without need for additional induction therapy beyond the planned end date
Number of Participants With Treatment Failures	week 21	Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States