Vancomycin-Associated Nephrotoxicity

September 30, 2022 updated by: Vanessa Stevens, University at Buffalo

Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure

The primary goal of this study is to determine if there is an association between greater exposure to vancomycin and the development of nephrotoxicity. The secondary goal is to estimate the costs to the hospital associated with these nephrotoxic events.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A simple random sample of 400 patients treated with greater than 48 hours of intravenous vancomycin exposure during hospitalization during the time period from July 1, 2009 through June 30, 2010

Description

Inclusion Criteria:

  • 18 years or older at time of hospital admission
  • Had an absolute neutrophil count of ≥ 1000 cells/mm^3
  • Received > 48 hours of intravenous vancomycin therapy
  • Had one or more vancomycin trough levels reported within the 96 hours after therapy initiation
  • Had a baseline serum creatinine level of < 2.0 mg/dL and baseline creatinine clearance level of ≥ 30 mL/min

Exclusion Criteria:

  • Previous diagnosis of cystic fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients receiving vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to nephrotoxicity
Time Frame: within 72 hours post completion of vancomycin therapy
within 72 hours post completion of vancomycin therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital costs
Time Frame: until discharge
until discharge
Length of stay
Time Frame: until discharge
until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

Cubist Pharmaceuticals LLC

Investigators

  • Principal Investigator: Jack Brown, PharmD, State University of New York at Buffalo
  • Principal Investigator: Vanessa Stevens, PhD, Internal Medicine, Division of Epidemiology, University of Utah School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIS-000184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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