Cefdinir versus cefaclor in the treatment of uncomplicated urinary tract infection.

OBJECTIVE: This multicenter, double-blind, randomized, parallel-group study was conducted in Europe, South Africa, and Australia to compare the clinical and microbiologic efficacy and the tolerability of a cephalosporin antibiotic, cefdinir, with those of cefaclor in the treatment of uncomplicated urinary tract infection. METHODS: Patients were randomized in a 1:1 ratio to 5 days of treatment with either cefdinir 100 mg BID or cefaclor 250 mg TID. RESULTS: A total of 661 patients were randomized to treatment. They were 90% female, with a median age of 44 years. There were no clinically important differences between groups in terms of demographic characteristics or symptoms on admission. The most frequently isolated pathogens in admission urine cultures were Escherichia coli (383 patients), Proteus mirabilis (20 patients), Staphylococcus saprophyticus (14 patients), and Klebsiella pneumoniae (9 patients). Of the admission pathogens with documented susceptibility results, significantly more were resistant to cefaclor (6.7%) than to cefdinir (3.7%; P < 0.003). Significantly more admission isolates of E. coli were resistant to cefaclor (5.1%) than to cefdinir (2.0%; P < 0.007). A total of 383 patients were assessable for efficacy, 196 in the cefdinir group and 187 in the cefaclor group. Clinical cure rates and microbiologic response rates for cefdinir and cefaclor were statistically equivalent at 5 to 9 days posttherapy (test-of-cure visit), using a 95% CI approach. The rate of treatment-related adverse events was higher in cefdinir-treated patients (20.2%) than in cefaclor-treated patients (13.0%; P = 0.025), mainly due to the greater frequency of diarrhea in the former group. However, only 4 patients (1.2%) discontinued cefdinir treatment due to diarrhea. CONCLUSION: Empiric therapy with cefdinir appears to be a reasonable choice for patients with uncomplicated urinary tract infection in whom cephalosporin treatment is indicated.

A general practice comparative study of a new third-generation oral cephalosporin, cefixime, with amoxycillin in the treatment of acute paediatric otitis media.

A total of 325 eligible paediatric patients were entered into an open, randomised, multicentre general practice study to assess the comparative efficacy of a new third-generation oral cephalosporin, cefixime, with respect to that of amoxycillin in the treatment of acute otitis media. The dose of cefixime was 100 mg once daily (six months to five years), 200 mg once daily (five to 10 years) and 300 mg once daily (10 to 16 years). The dose of amoxycillin was as currently used by the participating general practitioners: 62.5 mg tds (six months to one year), 125 mg tds (one to seven years) and 250 mg tds (seven to 16 years). Both were in the form of an oral suspension. The two groups (160 patients on cefixime and 165 on amoxycillin) were comparable at study entry with respect to all parameters assessed. Overall there was a 95 per cent favourable clinical response seen in both groups (95 per cent confidence limits: 92 and 98 per cent respectively). Adverse events were comparable in both groups, except that there were more gastrointestinal side effects seen with cefixime (13 per cent) compared with amoxycillin (4 per cent), but only three patients in each group had to be withdrawn because of side effects. These results demonstrate that cefixime given once daily is a safe and effective alternative to amoxycillin in the treatment of acute otitis media in children, and also has the advantage of less frequent dosing.