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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01352936
First received: May 11, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition
Staphylococcus Aureus
Bacteremia

Study Type: Observational
Official Title: Comparison of Nephrotoxicity and Hospital Costs in Patients With Methicillin-Resistant Staphylococcus Aureus Bacteremia Who Received Vancomycin Versus Teicoplanin Therapy

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 190
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Groups/Cohorts
Experimental Group
Control Group

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Staphylococcus aureus patients

Criteria

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01352936

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Yuh-Mou Sue Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Yuh-Mou Sue, Department of Internal Medicine, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01352936     History of Changes
Other Study ID Numbers: 100007
Study First Received: May 11, 2011
Last Updated: May 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
nephrotoxicity
hospital cost
Staphylococcus aureus
bacteremia
vancomycin
teicoplanin

Additional relevant MeSH terms:
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Methicillin
Vancomycin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014