---
title: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
nct_id: NCT04648696
overall_status: TERMINATED
phase: PHASE4
sponsor: Wake Forest University Health Sciences
study_type: INTERVENTIONAL
primary_condition: Infection
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04648696.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04648696"
ct_last_update_post_date: 2024-02-14
last_seen_at: "2026-05-12T06:13:13.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

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

**NCT ID:** [NCT04648696](https://clinicaltrials.gov/study/NCT04648696)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** The study was closed due to slow enrollment.
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** Wake Forest University Health Sciences
- **Conditions:** Infection
- **Start Date:** 2021-03-03
- **Completion Date:** 2022-10-31
- **CT.gov Last Update:** 2024-02-14

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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
- **Intermittent infusion (II) group** (ACTIVE_COMPARATOR) — Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge

## 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
- **Vancomycin II** (DRUG) — Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge

## Primary Outcomes

- **Number of Nephrotoxicity in Subjects** _(time frame: 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 Outcomes

- **Number of Leukopenia in Subjects** _(time frame: week 8)_
- **Number of Infusion-related Reactions** _(time frame: week 8)_
- **Number of Serum Vancomycin Measurements Within Therapeutic Range** _(time frame: week 8)_
- **Number of Participants With Resolutions of Symptoms Associated With the Infection** _(time frame: week 8)_
- **Number of Participants With Treatment Failures** _(time frame: week 21)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.wake forest health sciences|winston-salem|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04648696.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04648696*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*