A double-blind randomized controlled trial of fusidic acid and metronidazole for treatment of an initial episode of Clostridium difficile-associated diarrhoea

Abstract

Objectives: Few treatment options are currently available to treat patients suffering from an initial episode of Clostridium difficile-associated diarrhoea (CDAD). Patients and methods: A prospective, randomized controlled, double-blind trial was conducted to compare the efficacy of fusidic acid and metronidazole for treatment of patients experiencing a first episode of CDAD. The primary outcomes were clinical cure and clearance of C. difficile toxin determined on days 8-13, and secondary outcomes were clinical recurrence and reappearance of C. difficile toxin evaluated on days 35-40. Results: Of the patients in the fusidic acid group, 83% were clinically cured in comparison to 93% in the metronidazole group (P = 0.116) at the first follow-up visit. Clearance of C. difficile toxin did not differ between the two groups at that time. Clinical recurrence and reappearance of C. difficile toxin were noted in 27% and in 13% of the patients receiving fusidic acid, respectively and in 29% and 10% of those given metronidazole at the second follow-up on days 35-40. Conclusion: Since three of the four primary and secondary outcomes were almost identical for the two groups, the results indicate that fusidic acid is as effective as metronidazole in curing an initial episode of CDAD and can therefore be considered as an adequate alternative for treatment of this disease. © The British Society for Antimicrobial Chemotherapy 2004; all rights reserved.