Cefaclor advanced formulation versus cefaclor in the treatment of pneumonia.

The use of cefaclor advanced formulation (cefaclor AF) in the treatment of pneumonia caused by susceptible organisms was investigated in a multi-center trial conducted in the United Kingdom and the United States. A total of 266 patients were enrolled in this double-blind, double-dummy, randomized, parallel study; 132 patients were treated with cefaclor AF and 134 patients received the reference drug cefaclor. Inclusion criteria were a diagnosis of lobar pneumonia or bronchopneumonia, with a positive sputum culture and an infiltrate on chest roentgenogram. Patients received either cefaclor AF (750 mg twice daily) or cefaclor (500 mg three times daily) for 10 to 14 days. Forty patients in the cefaclor AF group and 45 in the cefaclor group were evaluable for efficacy, with 37 (92.5%) and 43 (95.6%), respectively, showing a favorable posttherapy clinical response. Proven or presumed pathogen elimination was achieved in 87.5% and 86.7% of cases, respectively. Both study drugs demonstrated high levels of activity against Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), and Moraxella catarrhalis (including beta-lactamase-producing strains). There were no statistically significant differences between drugs in efficacy results. One or more side effects were reported by 42.4% of the patients treated with cefaclor AF and by 44.0% of those treated with cefaclor; diarrhea, nausea, headache, and respiratory disorders were the most common adverse events. No drug-related side effects were seen with a frequency or severity that would be unexpected with the use of oral cephalosporins. Cefaclor AF and cefaclor performed equally well with respect to clinical and bacteriologic response rates in the treatment of pneumonia.

Efficacy of cefaclor AF in the treatment of skin and skin-structure infections.

Cefaclor advanced formulation (cefaclor AF) was compared with cefaclor for the treatment of skin and skin-structure infections in a double-blind study at 28 centers in North America. Of the 563 patients originally randomized, 278 patients received cefaclor AF (375 mg twice daily) and 285 patients received cefaclor (250 mg three times daily). A total of 154 patients treated with cefaclor AF and 157 patients treated with cefaclor qualified for the efficacy analysis after completing 7 days of therapy. At the post-therapy visit, favorable clinical response rates for evaluable patients were 97.4% in the cefaclor AF group and 94.9% in the cefaclor group; favorable bacteriologic response rates were 85.7% and 84.1%, respectively. At the late post-therapy evaluation, 7 to 14 days after completion of therapy, favorable clinical response rates were 90.1% in the cefaclor AF group versus 89.9% in the cefaclor group, and favorable bacteriologic response rates were 88.7% and 86.9%, respectively. No significant difference was seen between the groups in clinical or bacteriologic efficacy at either evaluation or in the frequency of nature of side effects reported during the study.