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OpenTrials
Completed

NCT Number: NCT01216540

Vancomycin-Associated Nephrotoxicity

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.

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Key information

Conditions

Nephrotoxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to nephrotoxicity

    Time frame: within 72 hours post completion of vancomycin therapy

Secondary outcomes

  1. Hospital costs

    Time frame: until discharge

  2. Length of stay

    Time frame: until discharge

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

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

Registry information

Official study title

Occurrence and Economic Impact of Nephrotoxicity Associated With Vancomycin Exposure

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2010
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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