This study will determine if rates of colonization and infection with 2 resistant Gram positive bacteria?methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE)?among patients in adult intensive care units (ICUs) are lower in ICUs that use an intensive infection control strategy plus standard care compared to ICUs that use standard care alone. The intensive control strategy involves: 1) identifying patients who are colonized with MRSA or VRE by reporting the results of surveillance cultures of the anterior nares and stool or perianal area; 2) Universal Gloving (use of gloves during interactions with the patient or the patient?s environment) until the patients are discharged or their surveillance culture results show they are not colonized with MRSA or VRE (whichever happens first); and 3) Contact Precautions (use of gloves and gowns during interactions with the patient or the patient?s environment) during care of patients who are colonized with MRSA or VRE. Standard care involves proper hand hygiene (handwashing or use of a waterless hand antiseptic) and use of Standard Precautions (use of gloves and other barriers as needed for interactions involving contact with mucous membranes, wounds, and body fluids) and collection of surveillance cultures, but not reporting of results to these sites. The surveillance cultures will be performed by obtaining swabs of the nose and stool or perianal area from patients upon admission to the ICU, at weekly intervals thereafter, and upon discharge from the ICU. The results of the surveillance cultures will be used to compare the rate of colonization with MRSA and VRE in ICUs using the intensive control strategy with those that use standard care alone.? ? Progress Report: This study is a multi-center trial supported by the National Institute of Allergy and Infectious Diseases (NIAID) and is conducted through the Bacteriology and Mycology Study Group, a clinical trials network funded by NIAID. Male and female patients, ages 18 and above, who are admitted to the MICU, SICU or MICU/SICU at one of the 20 participating sites are eligible for the study. The NIH Clinical Center provides the microbiology support for this protocol and has no direct patient contact. All microbiology specimens from participating sites are sent to the Department of Laboratory Medicine. The specimens are processed and recorded in the BAMBU database. In addition to providing microbiology support for the participating sites, several sub-studies are underway testing novel rapid diagnostic tools for MRSA and VRE against culture results. We have enrolled 20,059 patients and the study is now closed for enrollment. (Last day for enrollment was August 25, 2006). Data analysis is underway and should be complete by years end.
| Huskins, W Charles; O'Grady, Naomi P; Samore, Matthew et al. (2007) Design and methodology of the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR-ICU) trial. Infect Control Hosp Epidemiol 28:245-6;author reply 246-8 |
