A double-blind randomized controlled trial of fusidic acid and metronidazole for treatment of an initial episode of Clostridium difficile-associated diarrhoea.
OBJECTIVE
Few treatment options are currently available to treat patients suffering from an initial episode of Clostridium difficile-associated diarrhoea (CDAD).


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.


CONCLUSIONS
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.
Wullt
Marlene
M
Department of Infectious Diseases, University Hospital, Malmö, Sweden. marlene.wullt@skane.se
Odenholt
Inga
I
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001427:Bacterial Toxins / Q000378:metabolism; D016360:Clostridioides difficile; D003967:Diarrhea / Q000188:drug therapy* / Q000382:microbiology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005672:Fusidic Acid / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D013548:Sweden; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D001427:Bacterial Toxins; D008795:Metronidazole; D005672:Fusidic Acid