Vancomycin-Associated Nephrotoxicity | NCT01216540

Studies
Vancomycin-Associated Nephrotoxicity

NCT01216540

Sponsor

University at Buffalo

Status

Completed

Last Update Posted

Oct 3, 2022Actual

Enrollment

398Actual

Phase

Not provided

Conditions

Nephrotoxicity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2022

Last Update Posted Date

Oct 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vanessa Stevens, Principal Investigator, University at BuffaloPrincipal Investigator

Lead Sponsor

University at BuffaloOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

398Actual

Label	Type	Description	Intervention Names
Patients receiving vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to nephrotoxicity		within 72 hours post completion of vancomycin therapy

Secondary Outcomes

Measure	Description	Time Frame
Hospital costs		until discharge
Length of stay		until discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jack Brown, PharmD	State University of New York at Buffalo	Principal Investigator
Vanessa Stevens, PhD	Internal Medicine, Division of Epidemiology, University of Utah School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center		Rochester	New York	14642	United States