Cefodizime in clinical use: a review of the clinical trial reports

The clinical efficacy of cefodizime has been tested in several open and comparative studies, above all in lower respiratory tract infections (LRTI) and uncomplicated urinary tract infections (UTI), performed in 151 centres in Europe, Latin America, South-Eastern Asia and South Africa. Of 3791 patients, 2260 could be evaluated for efficacy and safety. Comparative studies in LRTI were carried out vs cefotaxime and cefuroxime (301 vs 299 patients); both clinical and bacteriological results were superimposable (range of satisfactory clinical outcomes from 86% to 95%; bacteriological eradication 95% to 100%). In open studies (533 evaluable patients) the percentage of clinical successes ranged from 79.1% to 91.8% and the bacteriological eradication from about 87% to 90%, according to the type of infections. Comparative studies (cefodizime vs cefuroxime or ceftizoxime) in UTI again demonstrated the equivalence of treatment. In open studies (374 evaluable patients) the percentage of satisfactory clinical outcomes ranged from 84.6% in complicated upper UTI to 95.9% in lower uncomplicated UTI, with overall bacteriological eradication of 92.7%. Side effects could be evaluated in 5801 patients (Western and Japanese clinical studies); 3.79% of patients showed side effects (1.99% gastrointestinal disturbances, 0.9% rash or urticaria, 0.9% other effects); 1.13% of patients required discontinuation of treatment. No relevant changes in laboratory parameters were observed. Cefodizime has been shown to be an effective and safe agent in the treatment of LRTI and UTI caused by susceptible pathogens. A dosage regimen of 1 g every 12 h seems to be the most suitable schedule for the treatment of LRTI while 1 g every 12 h or 2 g every 24 h can equally well be adopted for treatment of UTI.