Antimicrobial Drug Use and Resistant Staphylococcus Aureus

Staphylococcus Aureus Clinical Trial

Official title:

Antimicrobial Drug Use and Resistant Staphylococcus Aureus in a Network of Academic Medical Center Hospitals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075451
• Other study ID #: PT104711
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: May 17, 2013
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Staphylococcus Aureus

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School ofPharamcy	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Cubist Pharmaceuticals LLC, University HealthSystem Consortium

Country where clinical trial is conducted

United States, 

References & Publications (4)

MacDougall C, Polk RE. Variability in rates of use of antibacterials among 130 US hospitals and risk-adjustment models for interhospital comparison. Infect Control Hosp Epidemiol. 2008 Mar;29(3):203-11. doi: 10.1086/528810. — View Citation

Pakyz A, Powell JP, Harpe SE, Johnson C, Edmond M, Polk RE. Diversity of antimicrobial use and resistance in 42 hospitals in the United States. Pharmacotherapy. 2008 Jul;28(7):906-12. doi: 10.1592/phco.28.7.906. — View Citation

Pakyz AL, MacDougall C, Oinonen M, Polk RE. Trends in antibacterial use in US academic health centers: 2002 to 2006. Arch Intern Med. 2008 Nov 10;168(20):2254-60. doi: 10.1001/archinte.168.20.2254. — View Citation

Pakyz AL, Oinonen M, Polk RE. Relationship of carbapenem restriction in 22 university teaching hospitals to carbapenem use and carbapenem-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2009 May;53(5):1983-6. doi: 10.1128/AAC.01535-08. Epub 2009 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between Antimicrobial Stewardship Program and Infection Control efforts, antibacterial drug use and rates of hVISA and other resistant staphylococci.	Rates of hVISA and Staph.aureus with MIC creep to vancomycin	2008 and 2009	No