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Abstract
In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral re-aspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p<:0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p<0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.
