- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01352936
Comparison of Nephrotoxicity and Hospital Costs in Patients With Methicillin-Resistant Staphylococcus Aureus Bacteremia Who Received Vancomycin Versus Teicoplanin Therapy
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Taipei Medical University - WanFang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Cohorts and Interventions
Group / Cohort |
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Control Group
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Experimental Group
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Collaborators and Investigators
Investigators
- Principal Investigator: Yuh-Mou Sue, Taipei Medical University WanFang Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100007
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