Vancomycin-Associated Nephrotoxicity

NCT ID: NCT01216540

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nephrotoxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients receiving vancomycin

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role collaborator

University at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Stevens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack Brown, PharmD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Vanessa Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Internal Medicine, Division of Epidemiology, University of Utah School of Medicine

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IIS-000184

Identifier Type: -

Identifier Source: org_study_id

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