Clinical trial NCT01075451: Antimicrobial Drug Use and Resistant Staphylococcus Aureus
Official title: Antimicrobial Drug Use and Resistant Staphylococcus Aureus in a Network of Academic Medical Center Hospitals.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Keywords: Staphylococcus aureus
Antimicrobial Stewardship
Antibacterial resistance
Vancomycin
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University HealthSystem Consortium
name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2010-02-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aggregate antibacterial drug use from adult inpatients at 60 UHC hospitals for 2006 - 2009

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.

Eligibility criteria: Inclusion Criteria:

* NA

Exclusion Criteria:

* NA

Primary outcomes:
measure: Association between Antimicrobial Stewardship Program and Infection Control efforts, antibacterial drug use and rates of hVISA and other resistant staphylococci.
timeFrame: 2008 and 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School ofPharamcy
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ron E Polk, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.