Vancomycin-Associated Nephrotoxicity

Sponsor

University at Buffalo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01216540

Collaborator

Cubist Pharmaceuticals LLC (Industry)

400

Enrollment

Location

Duration (Months)

80.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotoxicity

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2011

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Patients receiving vancomycin

Outcome Measures

Primary Outcome Measures

Time to nephrotoxicity [within 72 hours post completion of vancomycin therapy]

Secondary Outcome Measures

Hospital costs [until discharge]
Length of stay [until discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

University at Buffalo
Cubist Pharmaceuticals LLC

Investigators

Principal Investigator: Jack Brown, PharmD, State University of New York at Buffalo
Principal Investigator: Vanessa Stevens, PhD, State University of New York at Buffalo