Comparison of Nephrotoxicity and Hospital Costs in Patients With Methicillin-Resistant Staphylococcus Aureus Bacteremia Who Received Vancomycin Versus Teicoplanin Therapy

Staphylococcus aureus, the most virulent of the many staphylococcal species, has been recognized as one of the most important and lethal human bacterial pathogens. With the increased incidence of methicillin-resistant staphylococcus aureus (MRSA) infection in community and hospitalized patients, MRSA infections are associated with greater lengths of stay, higher mortality, and increased costs. Vancomycin and teicoplanin, are the two most commonly used glycopeptides and are the first-choice of treatment for MRSA infection. Vancomycin-induced nephrotoxicity is still a point of controversy. Teicoplanin is not known to have any nephrotoxicity. Acute kidney injury is a common complication of critical illness, which is reported in 5 to 7% of hospitalized patients. It is associated with significantly increased mortality, length of stay, and costs across a broad spectrum of conditions.

Study Overview

Status

Unknown

Detailed Description

In this retrospective observational study, data collection was performed using the patient list extracted from the medical management system of Taipei Medical University-Wan Fang Hospital. Hospitalized patients who had been prescribed either vancomycin or teicoplanin for treating bloodstream infection caused by MRSA and had at least one serum creatinine data within 7 days after initiating glycopeptide therapy were recruited for this study. The major outcome variables of interest were the new onset of nephrotoxicity, which was defined as decrease of glomerular filtration rate (GFR) for more than 25% or 50% from baseline based on serial serum creatinine (SCr) measurements. Other variables including age at admission, gender, comorbidities, laboratory data, concurrent medications (e.g., drug name, dose, route, dosing interval, starting date and end date), and medical cost information were also obtained from the database.

We performed this observational clinical study with 2 main goals: (1) to determine the rate of nephrotoxicity and mortality in patients with MRSA bacteremia treated with vancomycin or teicoplanin; (2) to determine whether vancomycin-associated nephrotoxicity increase length of stay and costs.

Study Type

Observational

Enrollment (Anticipated)

190

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

      • Taipei, Taiwan
        • Taipei Medical University - WanFang Hospital

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Staphylococcus aureus patients

Description

Inclusion Criteria:

  • Hospitalized patients who had been prescribed either vancomycin or teicoplanin for treating bloodstream infection caused by MRSA and had at least one serum creatinine data within 7 days after initiating glycopeptide therapy were recruited for this study.

Exclusion Criteria:

  • Patients who aged less than 15 years at admission were excluded. Those who switch treatment from vancomycin to teicoplanin or vise versa during the hospitalization were also excluded to avoid any possible carryover effect. Because the main objectives of this study were to compare the magnitude and consequences of nephrotoxicity associated with the two study medications, patients who underwent dialysis before the glycopeptides treatment were further excluded.

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?

Cohorts and Interventions

Group / Cohort
Control Group
Experimental Group

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yuh-Mou Sue, Taipei Medical University WanFang Hospital

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

January 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2011

More Information

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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