Randomized comparison of linezolid (PNU-100766) versus oxacillin-dicloxacillin for treatment of complicated skin and soft tissue infections.

This randomized, double-blind, multicenter trial compared the efficacy and safety of linezolid, an oxazolidinone, with those of oxacillin-dicloxacillin in patients with complicated skin and soft tissue infections. A total of 826 hospitalized adult patients were randomized to receive linezolid (600 mg intravenously [i.v.]) every 12 h or oxacillin (2 g i.v.) every 6 h; following sufficient clinical improvement, patients were switched to the respective oral agents (linezolid [600 mg orally] every 12 h or dicloxacillin [500 mg orally] every 6 hours). Primary efficacy variables were clinical cure rates in both the intent-to-treat (ITT) population and clinically evaluable (CE) patients and microbiological success rate in microbiologically evaluable (ME) patients. Safety and tolerability were evaluated in the ITT population. Demographics and baseline characteristics were similar across treatment groups in the 819 ITT patients. In the ITT population, the clinical cure rates were 69.8 and 64.9% in the linezolid and oxacillin-dicloxacillin groups, respectively (P = 0.141; 95% confidence interval -1.58 to 11. 25). In 298 CE linezolid-treated patients, the clinical cure rate was 88.6%, compared with a cure rate of 85.8% in 302 CE patients who received oxacillin-dicloxacillin. In 143 ME linezolid-treated patients, the microbiological success rate was 88.1%, compared with a success rate of 86.1% in 151 ME patients who received oxacillin-dicloxacillin. Both agents were well tolerated; most adverse events were of mild-to-moderate intensity. No serious drug-related adverse events were reported in the linezolid group. These data support the use of linezolid for the treatment of adults with complicated skin and soft tissue infections.

A screening level probabilistic risk assessment of mercury in Florida Everglades food webs.

A screening level probabilistic assessment of risks was performed on three species of piscivorous wildlife at the top of Everglades aquatic food webs: the American alligator (Alligator mississippiensis), the great egret (Egretta alba), and the raccoon (Procyon lotor varius). Ranges of dietary exposure concentrations (and probability distribution functions) were derived for two general areas of the Everglades: Shark Slough and the southcentral Everglades (highly contaminated with Hg), and the northern Everglades (a lower Hg contaminated area in and near Water Conservation Area 1). Ranges of toxicity reference values and probability distribution functions were derived from literature on the toxicity of dietary methyl Hg to birds and mammals. Probability distributions of risk estimates for each receptor were generated using Monte Carlo simulations and indicated that piscivorous wildlife feeding in the south-central region of the Everglades are at high risk from consumption of Hg-contaminated prey. Alligators had 100% exceedences of chronic risk thresholds, and great egrets had 99% exceedences. In the northern Everglades, exceedences of chronic risk thresholds were substantially lower but were still present (6-34% exceedences). Results support previous studies suggesting that top predators of the Everglades may be at risk from Hg contamination and indicate that Hg risks are location-dependent.