NCT02764359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

May 2, 2016

Last Update Submit

February 1, 2020

Conditions

InfectionSepsisObesity

Outcome Measures

Primary Outcomes (1)

  • Time to attain therapeutic vancomycin concentrations

    < 7 days

Secondary Outcomes (6)

  • Reported adverse events

    48 hours post initial vancomycin dose

  • Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose

    12 hours

  • Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose

    12 hours

  • Intensive care unit length of stay

    30 days

  • Hospital length of stay

    30 days

  • +1 more secondary outcomes

Study Arms (2)

IV Vancomycin loading dose- higher

EXPERIMENTAL

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

Drug: IV vancomycin

IV Vancomycin loading dose- lower

EXPERIMENTAL

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

Drug: IV vancomycin

Interventions

IV vancomycinDRUG

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.

IV Vancomycin loading dose- higherIV Vancomycin loading dose- lower

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMC Health Systems

Charleston, West Virginia, 25304, United States

RECRUITING

MeSH Terms

Conditions

InfectionsSepsisObesity

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

William Payne, MD

CONTACT

304-388-6004Murnau@aol.com

Adam Crawford, DO

CONTACT

304-388-6004acrawford@osteo.wvsom.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Physician

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 6, 2016

Study Start

August 1, 2016

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

US(1)