[Clinical efficacy and safety of spiramycin and clarithromycin in the treatment of outpatients with lower respiratory tract infections].
Macrolide antibiotics have a broad spectrum of activities against the common pathogens responsible for lower respiratory tract infections, therefore for over 40 years they have been useful in treatment of these diseases. The aim of this open randomised multicentre trial is to compare the efficacy and safety of spiramycin, one of the first macrolides, to clarithromycin, a new generation macrolide, in their normal condition of use in patient presenting with acute non-complicated lower respiratory tract infections. 55 adult non-hospitalised patients with clinical diagnosis of bronchitis or pneumonia were randomised to receive either spiramycin 3 MIU twice daily or clarithromycin 500 mg twice daily for 7 or 10 days. For clinical evaluable patients, successful outcome was noted for 96.15% (25/26) spiramycin-treated patients and 96.43% (27/28) clarithromycin-treated patients. Clinically significant improvement in signs and symptoms was comparable between treatment groups. 2 patients in the spiramycin group (7.69%) and 3 in clarithromycin group (10.71%) complained of adverse events which severity was mild or moderate and did not require interruption of conducting antibioticotherapy. Efficacy and safety analysis showed that the two macrolides were equally effective and well-tolerated, at the given doses, for the treatment of lower respiratory tract infections and may play important role in out-patient therapy of these diseases.