Antimicrobial Drug Use and Resistant Staphylococcus Aureus

• ClinicalTrials.gov Identifier: NCT01075451
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: May 20, 2013
• Sponsor: Virginia Commonwealth University
• 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
• 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 *

• 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.
• 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.
• 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.
• 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.

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

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