WS02.1 Efficacy of a protocol for eradication of newly acquired MRSA: Results of the STAR-too trial

Abstract

Objectives The ST aph A ureus R esistance – t reat o r o bserve trial (STAR-too) evaluates microbiologic effectiveness of an eradication protocol (Rx) compared to observation (Obs.) in subjects with newly + MRSA cultures. The study was stopped early by the Data Monitoring Committee (DMC) due to efficacy. Methods Subjects were eligible if they were: within the first 6 months of their first MRSA positive culture, age 4–45 years, and had not received MRSA active antibiotics 4 weeks prior. Due to poor enrollment, the protocol was amended to allow patients with a recent + MRSA clinical isolate but negative at screening. The eradication protocol was: oral trimethoprim-sulfamethoxazole (or minocycline) plus rifampin and chlorhexidine mouthwash for two weeks, nasal mupirocin and chlorhexidine body wipes for five days, and environmental decontamination for 21 days. The primary endpoint was MRSA culture status at day 28. Results Among 42 patients (45% female, mean age 12.3±6.8 years, baseline FEV 1 % predicted 98.7±18.7) randomized at the time of the DMC review, 39 had evaluable culture results. Seventeen (81%) were MRSA negative in the Rx arm and 4 (22%) in the Obs. arm at day 28 (diff.: 59%, 95% CI: 28–76%). Among 27 MRSA positive at screening, 8 (67%) were MRSA neg. in the Rx arm compared to 2 (13%) in the Obs. arm (diff.: 53%, 95% CI: 16–75%) at day 28. Exacerbation rate up to day 28 was reduced in the Rx arm vs. Obs. arm [rate ratio 0.40 (0.08, 1.52)]. Conclusion This MRSA eradication protocol for newly acquired MRSA demonstrated microbiologic efficacy with a large treatment effect. No safety concerns were raised. Final primary efficacy data will be presented. CFF TDN. Funding: CFF.