Once‐Daily, High‐Dose Levofloxacin versus Ticarcillin‐Clavulanate Alone or Followed by Amoxicillin‐Clavulanate for Complicated Skin and Skin‐Structure Infections: A Randomized, Open‐Label Trial

Abstract

We report a randomized, double-blind, multicenter trial in which amphotericin B colloidal dispersion (ABCD [Amphotec]; 6 mg/kg/day) was compared with amphotericin B (AmB; 1.0–1.5 mg/kg/day) for the treatment of invasive aspergillosis in 174 patients. For evaluable patients in the ABCD and AmB treatment groups, respective rates of therapeutic response (52% vs. 51%; P = 1.0), mortality (36% vs. 45%; P =.4), and death due to fungal infection (32% vs. 26%; P =.7) were similar. Renal toxicity was lower (25% vs. 49%; P =.002) and the median time to onset of nephrotoxicity was longer (301 vs. 22 days; P <.001) in patients treated with ABCD. Rates of drug-related toxicity in patients receiving ABCD and AmB, respectively, were 53% versus 30% (chills), 27% versus 16% (fever), 1% versus 4% (hypoxia) and 22% versus 24% (toxicity requiring study drug discontinuation). ABCD appears to have equivalent efficacy and superior renal safety, compared with AmB, in the treatment of invasive aspergillosis. However, infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving AmB