Randomized double-blind trial of the comparative efficacy and safety of cefpodoxime proxetil and cefaclor in the treatment of acute community-acquired pneumonia

Abstract

A randomized, controlled, double-blind, double-dummy, multicenter study compared the efficacy and safety of cefpodoxime proxetil with that of cefaclor in the outpatient treatment of community-acquired pneumonia. A total of 325 patients received 7 to 14 days of either 200 mg of cefpodoxime as cefpodoxime proxetil twice daily (n = 216) or 500 mg of cefaclor three times daily (n = 109). All study criteria were met by 125 patients (cefpodoxime, 77; cefaclor, 48). Streptococcus pneumoniae and Haemophilus influenzae were the most commonly identified pathogens. Of 198 pathogenic bacteria isolated from sputum, cefpodoxime susceptibility was tested in 178 and cefaclor susceptibility in 181. Isolates were more susceptible to cefpodoxime than to cefaclor ( P = 0.001): 94% were susceptible to cefpodoxime and 82% to cefaclor; 3% were moderately susceptible to cefpodoxime and 5% to cefaclor; 3% were resistant to cefpodoxime and 13% were resistant to cefaclor. Clinical outcome in the two treatment groups was similar: 77% of cefpodoxime-treated patients and 71% of cefaclor-treated patients were cured; 19% of cefpodoxime-treated and 25% of cefaclor-treated patients improved; and 4% of patients in each group were considered treatment failures. Gastrointestinal complaints were the most frequently reported drug-related adverse event (10%) in the cefpodoxime group, and dermatologic problems (5%) were the most commonly encountered drug-related adverse event in the cefaclor group. Overall frequencies of drug-related adverse events were similar (16% for cefpodoxime vs 14% for cefaclor) in the two groups. Cefpodoxime proxetil was as effective and as well tolerated as cefaclor in the outpatient treatment of community-acquired pneumonia.