Chlorhexidine Versus Routine Bathing to Prevent Multi Drug-Resistant Organisms and All-Cause Bloodstream Infection in General Medical and Surgical Units: The ABATE Infection Cluster Randomized Trial

Background: Universal skin and nasal decolonization reduces multidrug-resistant pathogens and bloodstream infections in intensive care units. The effect of universal decolonization on pathogens and infections in non-critical care units is unknown. Methods: A two-arm cluster-randomized trial was conducted in 53 hospitals in the Hospital Corporation of America Healthcare system. Hospitals were randomized and their participating non-critical care units assigned to either routine care or daily chlorhexidine bathing for all patients plus mupirocin for known methicillin-resistant Staphylococcus aureus (MRSA) carriers. The trial involved a 12-month baseline (Mar 2013-Feb 2014) and 21-month intervention (Jun 2014-Feb 2016). Primary outcome was MRSA or vancomycin-resistant enterococcus (VRE) clinical cultures attributed to participating units, and secondary outcome was all-pathogen bloodstream infection. Proportional hazards models assessed differences in outcome reductions across arms, accounting for clustering by hospital. Post-hoc subgroup analyses were performed. Findings: There were 189,081 patients in the baseline period and 339,902 patients in the intervention period across 194 non-critical care units in 53 hospitals. Hazard ratios for MRSA/VRE clinical isolates during intervention vs. baseline periods were 0·87 (CI:0·79, 0·95) for routine care, and 0·79 (CI:0·73, 0·87) for decolonization (p=0·17), and 0·96 (CI:0·85, 1·08) and 0·90 (0·81, 1·01) for all-pathogen bloodstream infection, respectively (p=0·44). Among patients with central venous catheters, midline catheters, or lumbar drains, the hazard ratio for MRSA/VRE clinical cultures was 1·17 (CI:1·00, 1·37) for routine care and 0·80 (CI:0·69, 0·92) for decolonization, (p=0·0004), and the hazard ratio for all-pathogen bloodstream infections was 1·13 (CI:0·96, 1·33) for routine care and 0·82 (CI:0·71, 0·94) for decolonization, p=0·004. Interpretation: Decolonization with universal chlorhexidine bathing and targeted mupirocin for MRSA carriers did not reduce multidrug-resistant organisms or all-pathogen bloodstream infection in all non-critical care patients, but patients with invasive devices experienced 37% reduction in MRSA/VRE and 31% reduction in bloodstream infections. Clinical Trial Registration Number: clinicaltrials.gov Identifier: NCT0206386 Funding Statement: This project was funded by the National Institutes of Health Common Fund and administered by the National Institute of Allergy and Infectious Diseases (UH2/UH3 AT007769‐01 (Huang)). Declaration of Interest: Sage Products and Molnlycke contributed antiseptic chlorhexidine product to this trial. Investigators are also conducting other studies in which contributed antiseptic product is provided to participating hospitals and nursing homes from Stryker (Sage Products) (KK, LH, MHC, MKH, RAW, SSH), 3M (LH, SSH), Clorox (CS, ES, JH, JM, JP, KH, KK, LH, LS, MHC, MKH, RAW, RP, SSH, TRA), Xttrium (LH, SSH), and Medline (CS, ES, JH, JM, JP, KH, KK, LH, LS, MHC, MKH, RAW, RP, SSH, TRA). Investigator-initiated grant funds were received from Clorox (MKH, MHC, LS, KH, RP). Companies contributing product or providing grant funds have no role in the design, conduct, analysis, or publication of the ABATE Infection Trial or other studies conducted by these investigators. All other authors have no disclosures. Ethics Approval Statement: Central IRB approval was obtained from Harvard Pilgrim Health Care with a waiver of informed consent. All participating hospitals formally ceded IRB oversight to the HPHC IRB, except for the designated medical center IRB (Chippenham & Johnston Willis Hospitals) that provided prisoner oversight for the trial.