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Antimicrobial Drug Use and Resistant Staphylococcus Aureus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075451
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : May 20, 2013
Sponsor:
Collaborators:
University HealthSystem Consortium
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date February 23, 2010
First Posted Date February 25, 2010
Last Update Posted Date May 20, 2013
Study Start Date January 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2010)
Association between Antimicrobial Stewardship Program and Infection Control efforts, antibacterial drug use and rates of hVISA and other resistant staphylococci. [ Time Frame: 2008 and 2009 ]
Rates of hVISA and Staph.aureus with MIC creep to vancomycin
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antimicrobial Drug Use and Resistant Staphylococcus Aureus
Official Title Antimicrobial Drug Use and Resistant Staphylococcus Aureus in a Network of Academic Medical Center Hospitals.
Brief Summary The purpose of this investigation is to study the relationships between antimicrobial stewardship program efforts, antimicrobial drug use, and infection control efforts to the incidence rates of hospital acquired infections with Staphylococcus aureus in a sample of US academic medical center hospitals.
Detailed Description Hospitalized patients can become infected with a variety of microorganisms, but infections caused by Staphylococcus aureus (i.e., "staph" infections) are particularly common. The main strategy to reduce the number of patients infected with Staph. aureus is to decrease cross-transmission from one patient to another. In addition, increasing evidence suggests that improvements in antimicrobial drug use--promoted by hospital Antimicrobial Stewardship programs (ASPs) -- may also favorably impact rates of Staph. aureus infections. While many Staphylococcal strains remain susceptible to an old drug called methicillin (methicillin-susceptible Staph aureus, or MSSA), many Staph. aureus are methicillin-resistant (MRSA). The drug of choice for MRSA has historically been vancomycin, and vancomycin is now the most commonly prescribed antibiotic in US teaching hospitals. Vancomycin-resistant Staph. aureus (VRSA) is still uncommon, but some Staph. aureus are developing "low level" resistance to vancomycin. These strains are often called S. aureus with MIC "creep" to vancomycin (SA-MICcreep), and Staphylococcus aureus with Heterogeneous Resistance to Vancomycin (hVISA), but the epidemiology, clinical significance and risk factors for these organisms are not well described. We will survey UHC participating hospitals to learn more about these organisms, the drug and ASP related risk factors, and whether hospitals are trying to identify these organisms.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Aggregate antibacterial drug use from adult inpatients at 60 UHC hospitals for 2006 - 2009
Condition Staphylococcus Aureus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2013)
41
Original Estimated Enrollment
 (submitted: February 24, 2010)
100
Actual Study Completion Date May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • NA

Exclusion Criteria:

  • NA
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01075451
Other Study ID Numbers PT104711
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators
  • University HealthSystem Consortium
  • Cubist Pharmaceuticals LLC
Investigators
Principal Investigator: Ron E Polk, Pharm.D. Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date May 2013