Project CLEAR (Changing Lives by Eradicating Antibiotic Resistance) randomized controlled trial (RCT): Serial decolonization of recently hospitalized methicillin-resistant Staphylococcus aureus (MRSA) carriers reduces risks of MRSA infections and all-cause infections in the 1-year post-hospitalization

Background:

Hospitalized MRSA carriers have an increased risk of infection that continues beyond hospital discharge. 60% of invasive MRSA disease occurs during this period. Serial decolonization following hospital discharge may provide protection.

Methods:

We conducted a RCT of hygienic education (E) vs. education plus serial topical decolonization (D) for recently discharged patients with a confirmed MRSA culture. Decolonization consisted of oral chlorhexidine (CHG) mouth wash, CHG bath/shower, and nasal mupirocin for 5 days twice a month for 6 months. Subjects were enrolled between Jan 2011-June 2014 and followed for one year. Primary outcome was time to MRSA infection defined by CDC criteria. Secondary outcomes included MRSA infection by clinical judgment, all infections by CDC criteria, and all infections by clinical judgment. Infection outcomes were based on blinded chart review of outpatient and inpatient visits by 2 infectious diseases physicians. We evaluated intention-to-treat and as-treated groups using proportional hazards models.

Results:

2,137 patients were enrolled (E = 1,069; D = 1,068). Total days in trial were D: 260,058 days (median 360.0) and E: 274,483 days (median 350.5). 6,033 unique medical records were reviewed. A significant reduction in MRSA infections and all-cause infections was seen (Table 1, Figure 1), with higher benefit seen in the D subset with full protocol adherence (51% of total D time) (Table 2). 28% of all MRSA infections involved bacteremia. Infections accrued at a stable rate across the one year follow up period. 40 adverse events deemed potentially related to study products were reported (CHG mouth wash (11), CHG soap (21), mupirocin (8)).

Conclusion:

In a RCT of over 2,000 patients, topical decolonization with mupirocin and CHG resulted in a 30% reduction in MRSA infection and a 16% reduction in all-cause infection in the one-year post-discharge period. For those (half) who were fully adherent to the 6 month protocol, reductions of 44% in MRSA infection and 40% in all-cause infection were seen.