Recruiting

Vancomycin vs. Vancomycin

Sponsor:

CAMC Health System

Code:

NCT02764359

Conditions

Infection

Sepsis

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IV vancomycin

Study Details

Brief summary:

Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.

This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.

Conditions

Infection

Sepsis

Obesity

Study ID

NCT02764359

Start date

Aug 1, 2016

Status verified date

Feb, 2020

Completion date

Jan 22, 2021

Anticipated

Primary completion date

Jan 22, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department
  • Weight >100kg
  • Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital

Exclusion Criteria:

  • Any patient <18 years of age
  • Patients on dialysis or with unstable renal function (a change of >0.5 mg/dL in SCr concentration in patients with a SCr of <2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV Vancomycin loading dose- higher

IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg

experimental: IV Vancomycin loading dose- lower

IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg

Interventions

IV vancomycin

IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.

Primary outcome measure

  • Time to attain therapeutic vancomycin concentrations [ Time Frame: < 7 days ]

Central Contacts and Locations

Central contacts

Locations

CAMC Health Systems

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Principal Investigator:

William Payne, MD

More Information

Sponsor

CAMC Health System

Last update posted

Feb 5, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2020-02-05.