There are several U.S. FDA-cleared molecular respiratory virus panels available today, each with advantages and disadvantages. This study compares four multiplex panels, the BioFire Diagnostics FilmArray RP (respiratory panel), the GenMark Dx eSensor RVP (respiratory viral panel), the Luminex xTAG RVPv1, and the Luminex xTAG RVP fast. Three hundred specimens (200 retrospective and 100 consecutive) were tested using all four platforms to determine performance characteristics. The overall sensitivity and specificity, respectively, and 95% confidence interval (CI; in parentheses) for each panel were as follows: FilmArray RP, 84.5% (
Xpert-based strategies significantly reduced AII duration compared with the smear-based strategy. The 2-specimen Xpert strategy was most efficient in minimizing AII time while identifying all tuberculosis cases among individuals with presumptive tuberculosis in this low-burden setting.
In this U.S. study, most MRSA isolates in the pediatric CF population were SCCmec II PVL negative. Rates of resistance were low, including to older and orally available antibiotics such as trimethoprim-sulfamethoxazole.
Objective
To evaluate microbiologic effectiveness, i.e. culture negativity of a non-blinded eradication protocol (Rx) compared to observation (Obs) in clinically stable cystic fibrosis participants with newly positive MRSA cultures.
Design
This non-blinded trial randomized participants ages 4-45 years with first or early (≤2 positive cultures within 3 years) MRSA positive culture without MRSA-active antibiotics within 4 week 1:1 to Rx or Obs. The Rx protocol was: oral trimethoprim-sulfamethoxazole or if sulfa-allergic, minocycline plus oral rifampin; 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
Between April 1, 2011 to September 2014, forty-five participants (44% female, mean age 11.5 years) were randomized (24 Rx, 21 Obs). At Day 28, 82% (n=18/22) of participants in the Rx-arm compared to 26% (n=5/19) in Obs-arm were MRSA negative. Adjusted for interim monitoring, this difference was 52% (95% CI: 23%, 80%; p<0.001). Limiting analyses to participants who were MRSA positive at the screening visit, 67% (8/12) in the Rx and 13% (2/15) in the Obs-arm were MRSA negative at Day 28, adjusted difference: 49% (95% CI: 22%,71%, p<0.001). Fifty-four percent in the Rx compared to 10% participants in the Obs-arm remained MRSA negative through Day 84. Mild gastrointestinal side effects were higher in the Rx-arm.
Conculsions
This MRSA eradication protocol for newly acquired MRSA demonstrated microbiologic efficacy with a large treatment effect.
Trial Registration
www.clinicaltrials.gov NCT01349192
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