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Vancomycin-Associated Nephrotoxicity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University at Buffalo.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT01216540
First received: October 6, 2010
Last updated: October 8, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Nephrotoxicity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Time to nephrotoxicity [ Time Frame: within 72 hours post completion of vancomycin therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital costs [ Time Frame: until discharge ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: until discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients receiving vancomycin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216540

Contacts
Contact: Vanessa Stevens, PhD (585) 273-3526 vstevens@buffalo.edu

Locations
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Principal Investigator: Jack Brown, PharmD            
Principal Investigator: Vanessa Stevens, PhD            
Sponsors and Collaborators
University at Buffalo
Cubist Pharmaceuticals
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
  More Information

No publications provided

Responsible Party: Jack Brown, Clinical Assistant Professor, State University of New York at Buffalo School of Pharmacy and Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01216540     History of Changes
Other Study ID Numbers: IIS-000184
Study First Received: October 6, 2010
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University at Buffalo:
vancomycin
nephrotoxicity
length of stay
costs

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013