Popis: |
The safety and efficacy of two dose regimens of cefodizime (CAS 69739-16-8, HR 221) in hospitalized patients with lower respiratory tract infections were assessed in two consecutive studies. Sputum bacteriology, chest X-ray and a safety laboratory check were performed at baseline and after therapy. In order to compensate for the lack of a double-blind design the evaluation was conducted as a clinical intention-to-treat analysis. 32 patients (16 males, 16 females, mean age: 64 years) were admitted to study A and 42 subjects (30 males, 12 females, mean age: 66 years) to study B. The dosage regimens of cefodizime were 1 g b.i.d. (median 7 days) in study A and 2 g once daily (median 6 days) in study B. Parenchymal involvement was confirmed by chest X-ray in 56% of the patients in study A and 64% in study B, the remainder patients had acute exacerbations of chronic bronchitis with reasonable evidence of bacterial infection. The most frequent pathogens were Streptococcus pneumoniae and Haemophilus spp. The clinical cure rate was 97% in study A and 88% in study B. Eradication rates were 100% and 94%, respectively. No superinfection occurred. No adverse reactions were observed. In conclusion, a single daily injection of cefodizime 2 g achieved similar clinical and bacteriological cure rates to the standard dose regimen of 1 g b.i.d. |