Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04648696
• Other study ID #: IRB00069815
• Status: Terminated
• Phase: Phase 4
• Start date: March 3, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and outcomes associated between the two treatment modalities

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Nephrotoxicity in Subjects	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	week 8
Secondary	Number of Leukopenia in Subjects	Number of Subjects with White Blood Cell (WBC) < 4,000 x 103 cells/µL	week 8
Secondary	Number of Infusion-related Reactions	Flushing/Erythema /Rash/Red Man Syndrome	week 8
Secondary	Number of Serum Vancomycin Measurements Within Therapeutic Range	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	week 8
Secondary	Number of Participants With Resolutions of Symptoms Associated With the Infection	Number of Subjects without need for additional induction therapy beyond the planned end date	week 8
Secondary	Number of Participants With Treatment Failures	Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection	week 21