Susan S Huang1, Raveena Singh1, James A McKinnell1, Steven Park1, Adrijana Gombosev1, Samantha J Eells1, Daniel L Gillen1, Diane Kim1, Syma Rashid1, Raul Macias-Gil1, Michael A Bolaris1, Thomas Tjoa1, Chenghua Cao1, Suzie S Hong1, Jennifer Lequieu1, Eric Cui1, Justin Chang1, Jiayi He1, Kaye Evans1, Ellena Peterson1, Gail Simpson1, Philip Robinson1, Chester Choi1, Charles C Bailey1, James D Leo1, Alpesh Amin1, Donald Goldmann1, John A Jernigan1, Richard Platt1, Edward Septimus1, Robert A Weinstein1, Mary K Hayden1, Loren G Miller1. 1. From the Division of Infectious Diseases (S.S. Huang, R.S., S.P., D.K., S.R., T.T., C. Cao, S.S. Hong, J.L., E.C., J.C., J.H.), the Health Policy Research Institute (S.S. Huang), and the Department of Medicine (A.A.), University of California Irvine School of Medicine, and the Institute for Clinical and Translational Science (A.G.) and the Department of Statistics (D.L.G.), University of California Irvine, Irvine, the Infectious Disease Clinical Outcomes Research Unit, Division of Infectious Diseases, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance (J.A.M., S.J.E., R.M.-G., M.A.B., L.G.M.), the Department of Pathology and Laboratory Medicine, University of California Irvine School of Medicine, Orange (K.E., E.P.), Ventura County Medical Center, Ventura (G.S.), the Division of Infectious Disease, Hoag Hospital, Newport Beach (P.R.), the Division of Infectious Disease, St. Mary Medical Center (C. Choi), and MemorialCare Health System (J.D.L.), Long Beach, and the Division of Infectious Disease, Mission Hospital, Mission Viejo (C.C.B.) - all in California; the Institute of Healthcare Improvement, Cambridge (D.G.), and the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care, Boston (R.P.) - both in Massachusetts; the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta (J.A.J.); Texas A&M Health Science Center, Houston (E.S.); and Cook County Health and Hospitals System (R.A.W.) and the Division of Infectious Diseases, Rush University Medical Center (R.A.W., M.K.H.), Chicago.
Abstract
BACKGROUND:Hospitalized patients who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) are at high risk for infection after discharge. METHODS: We conducted a multicenter, randomized, controlled trial of postdischarge hygiene education, as compared with education plus decolonization, in patients colonized with MRSA (carriers). Decolonization involved chlorhexidine mouthwash, baths or showers with chlorhexidine, and nasal mupirocin for 5 days twice per month for 6 months. Participants were followed for 1 year. The primary outcome was MRSA infection as defined according to Centers for Disease Control and Prevention (CDC) criteria. Secondary outcomes included MRSA infection determined on the basis of clinical judgment, infection from any cause, and infection-related hospitalization. All analyses were performed with the use of proportional-hazards models in the per-protocol population (all participants who underwent randomization, met the inclusion criteria, and survived beyond the recruitment hospitalization) and as-treated population (participants stratified according to adherence). RESULTS: In the per-protocol population, MRSA infection occurred in 98 of 1063 participants (9.2%) in the education group and in 67 of 1058 (6.3%) in the decolonization group; 84.8% of the MRSA infections led to hospitalization. Infection from any cause occurred in 23.7% of the participants in the education group and 19.6% of those in the decolonization group; 85.8% of the infections led to hospitalization. The hazard of MRSA infection was significantly lower in the decolonization group than in the education group (hazard ratio, 0.70; 95% confidence interval [CI], 0.52 to 0.96; P=0.03; number needed to treat to prevent one infection, 30; 95% CI, 18 to 230); this lower hazard led to a lower risk of hospitalization due to MRSA infection (hazard ratio, 0.71; 95% CI, 0.51 to 0.99). The decolonization group had lower likelihoods of clinically judged infection from any cause (hazard ratio, 0.83; 95% CI, 0.70 to 0.99) and infection-related hospitalization (hazard ratio, 0.76; 95% CI, 0.62 to 0.93); treatment effects for secondary outcomes should be interpreted with caution owing to a lack of prespecified adjustment for multiple comparisons. In as-treated analyses, participants in the decolonization group who adhered fully to the regimen had 44% fewer MRSA infections than the education group (hazard ratio, 0.56; 95% CI, 0.36 to 0.86) and had 40% fewer infections from any cause (hazard ratio, 0.60; 95% CI, 0.46 to 0.78). Side effects (all mild) occurred in 4.2% of the participants. CONCLUSIONS: Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection than education alone. (Funded by the AHRQ Healthcare-Associated Infections Program and others; ClinicalTrials.gov number, NCT01209234 .).
RCT Entities:
BACKGROUND: Hospitalized patients who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) are at high risk for infection after discharge. METHODS: We conducted a multicenter, randomized, controlled trial of postdischarge hygiene education, as compared with education plus decolonization, in patients colonized with MRSA (carriers). Decolonization involved chlorhexidine mouthwash, baths or showers with chlorhexidine, and nasal mupirocin for 5 days twice per month for 6 months. Participants were followed for 1 year. The primary outcome was MRSA infection as defined according to Centers for Disease Control and Prevention (CDC) criteria. Secondary outcomes included MRSA infection determined on the basis of clinical judgment, infection from any cause, and infection-related hospitalization. All analyses were performed with the use of proportional-hazards models in the per-protocol population (all participants who underwent randomization, met the inclusion criteria, and survived beyond the recruitment hospitalization) and as-treated population (participants stratified according to adherence). RESULTS: In the per-protocol population, MRSA infection occurred in 98 of 1063 participants (9.2%) in the education group and in 67 of 1058 (6.3%) in the decolonization group; 84.8% of the MRSA infections led to hospitalization. Infection from any cause occurred in 23.7% of the participants in the education group and 19.6% of those in the decolonization group; 85.8% of the infections led to hospitalization. The hazard of MRSA infection was significantly lower in the decolonization group than in the education group (hazard ratio, 0.70; 95% confidence interval [CI], 0.52 to 0.96; P=0.03; number needed to treat to prevent one infection, 30; 95% CI, 18 to 230); this lower hazard led to a lower risk of hospitalization due to MRSA infection (hazard ratio, 0.71; 95% CI, 0.51 to 0.99). The decolonization group had lower likelihoods of clinically judged infection from any cause (hazard ratio, 0.83; 95% CI, 0.70 to 0.99) and infection-related hospitalization (hazard ratio, 0.76; 95% CI, 0.62 to 0.93); treatment effects for secondary outcomes should be interpreted with caution owing to a lack of prespecified adjustment for multiple comparisons. In as-treated analyses, participants in the decolonization group who adhered fully to the regimen had 44% fewer MRSA infections than the education group (hazard ratio, 0.56; 95% CI, 0.36 to 0.86) and had 40% fewer infections from any cause (hazard ratio, 0.60; 95% CI, 0.46 to 0.78). Side effects (all mild) occurred in 4.2% of the participants. CONCLUSIONS: Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection than education alone. (Funded by the AHRQ Healthcare-Associated Infections Program and others; ClinicalTrials.gov number, NCT01209234 .).
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