New findings from a large, randomized clinical trial that compared two infection control techniques are already being incorporated into practice within the network of U.S. community hospitals where the trial took place. The trial evaluated whether daily bathing with the antiseptic soap chlorhexidine (CHG) — and in those patients with methicillin-resistant Staphylococcus aureus (MRSA), adding the nasal antibiotic mupirocin — more effectively reduced hospital-acquired bacterial infections than bathing with ordinary soap and water. While no statistically significant difference between the two intervention groups was seen within the population overall, the researchers did find that one subset of patients — those with medical devices — experienced a substantial benefit if they received the CHG/mupirocin intervention.
The ABATE (Active Bathing to Eliminate) Infection trial was initiated through the National Institutes of Health’s Common Fund program and was managed by the National Institute of Allergy and Infectious Diseases (NIAID), an NIH component. Results of the study, which involved about 330,000 adult patients in non-intensive care units in the HCA Healthcare system, appear today in The Lancet. Susan S. Huang, M.D., M.P.H., of the University of California Irvine School of Medicine, led the research team.
During a five-month recruitment period, 53 community hospitals (comprising 194 non-ICU units) throughout the HCA Healthcare system were randomized to either the routine bathing arm or the CHG bathing plus mupirocin arm of the study. Five hospitals withdrew, leaving 24 hospitals in each arm of the 21-month-long intervention. During that period, the 330,000 patients enrolled in the trial had 1.3 million days of hospital care.
Within the overall study population, the research team found no statistically significant difference between the study arms. However, patients with medical devices, such as central venous catheters or lumbar drains, benefitted from the CHG/mupirocin intervention. Among that subset of patients, investigators recorded a 30 percent decrease in bloodstream infections and a nearly 40 percent decrease in antibiotic-resistant bacteria, including MRSA and vancomycin-resistant enterococcus, compared to rates seen in similar patients in the standard bathing arm of the trial. The benefit of CHG bathing for patients with devices is notable, said Dr. Huang. Although they represented only 12 percent of the total non-ICU patient population, patients with devices had a disproportionately high risk for bacterial infection: they accounted for 37 percent of MRSA and VRE clinical cultures and more than half of all bloodstream infections.
Classic clinical trials typically recruit and enroll patients one by one, and are often costly, labor-intensive and time-consuming. According to Dr. Huang, pragmatic trials complement the strengths of classic clinical trials, but because they are performed under “real world” conditions — for example, by weaving quality improvement strategies into existing care routines — they are usually less expensive.
In addition to Dr. Huang and collaborators at the University of California Irvine, the study team included investigators from HCA Healthcare, Harvard Medical School and Harvard Pilgrim Health Care Institute, Rush Medical College and the Centers for Disease Control and Prevention.
