Multi-center trial of clinical efficacy and safety of lexofloxacin in community- acquired respiratory infections in Russia

Abstract

The opened multi-center IV phase trial investigated clinical efficacy, tolerability and safety of levofloxacin in 1972 patients with com m unity-acquired respiratory infections (pneumonia, exacerbation of chronic bronchitis, acute and chronic sinusitis). The drug belongs to new "respiratory" quinolones having enhanced anti-pneumococcal activity. The trial involved 1011 males and 961 females aged 16 to 99 yrs (43.0±14.6 in average). Levofloxacin was given in the daily dose of 250 to 1000 mg (500 mg in 91% of the patients) and in most of them (in 93%) orally. The duration of the treatment was 5 to 12 days (7.0+1.8 days in average). Under the therapy with levofloxacin most of the patients demonstrated rapid improvement of main symptom s. The clinical efficacy was 94.2%; there was no effect in 107 (5.4% ) of the patients. The highest clinical efficacy of levofloxacin was noted in acute sinusitis (99% ), it was quite similar in other infectious diseases (92 to 93%). Adverse effects were found in 34 (1.7% ) of the patients but only 2 (0.1% ) cases required withdrawal of the drug. Digestive symptom s were the most frequent. Therefore, the results showed the high efficacy and safety of levofloxacin in com m unity-acquired respiratory infections at outpatient and inpatient facilities.