Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

NCT04648696 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00069815
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and outcomes associated between the two treatment modalities

Conditions

Infection

Keywords

infusion therapy; continuous infusions; nephrotoxicity; outpatient parenteral antibiotic therapy; vancomycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Leukopenia in Subjects

  week 8

• Number of Infusion-related Reactions

  week 8

• Number of Serum Vancomycin Measurements Within Therapeutic Range

  week 8

• Number of Participants With Resolutions of Symptoms Associated With the Infection

  week 8

• Number of Participants With Treatment Failures

  week 21

Study Arms (2)

continuous infusions (CI) group

ACTIVE COMPARATOR

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

Drug: Vancomycin CI

Intermittent infusion (II) group

ACTIVE COMPARATOR

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

Drug: Vancomycin II

Interventions

Vancomycin CI 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

Also known as: glycopeptide antibiotic

continuous infusions (CI) group

Vancomycin II DRUG

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

Also known as: glycopeptide antibiotic

Intermittent infusion (II) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: John Williamson, PhD
• Organization: Wake Forest University Health Sciences

johnwill@wakehealth.edu

336.713.3431

Study Officials

• John Williamson, PharmD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: March 3, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)