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 provides the microbiology for this protocol and has no direct patient contact. The Department of Laboratory Medicine at the NIH performs the microbiology on the samples collected at the participating sites. The NIH lab records the culture results in the BAMBU system. This study has enrolled 2982 patients over a 4 month baseline density data collection period. The 6 month intervention period for those ICUs randomized to the intensive control arm begins January 1, 2006. No data analysis has yet occurred.
| 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 |
