Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study.
BACKGROUND
Vancomycin is the only US Food and Drug Administration-approved drug for treatment of Clostridium difficile infection (CDI). Metronidazole has been widely used for this purpose but may be inferior to vancomycin, especially for hospitalized patients with severe disease. We report a prospective, double-blind, randomized controlled trial comparing nitazoxanide with vancomycin for treatment of CDI.


METHODS
Fifty patients with CDI were randomized to receive vancomycin or nitazoxanide for 10 days. An initial response was considered to be the absence of all CDI symptoms between days 11 and 13, and a final response was considered to be lack of symptom recurrence by day 31.


RESULTS
One patient fulfilled an exclusion criterion and was removed from the study. Twenty-seven patients received vancomycin, and 23 received nitazoxanide; 23 and 18 patients, respectively, completed the full course of treatment. Initial responses occurred in 20 (74%) of 27 patients treated with vancomycin and in 17 (77%) of 22 patients treated with nitazoxanide (95% confidence interval, -24% to +28%). In those who completed therapy, response rates were 87% (20 of 23 patients) in the vancomycin group and 94% (17 of 18 patients) in the nitazoxanide group (95% confidence interval, -18% to +30%). Times to complete resolution of symptoms were similar in the 2 groups (P = .55). Two patients in the vancomycin group and 1 patient in the nitazoxanide group experienced relapse within 31 days after beginning treatment. Sustained response rates were 78% (18 of 23 patients) for the vancomycin group, and 89% (16 of 18 patients) for the nitazoxanide group (95% confidence interval, -18% to +35%).


CONCLUSIONS
The small sample precludes conclusions about noninferiority of nitazoxanide to vancomycin. Nevertheless, this is the first recent randomized controlled trial to compare any antimicrobial agent other than metronidazole with vancomycin. Results suggest that nitazoxanide may be as effective as vancomycin in treating CDI.


BACKGROUND
ClinicalTrials.gov identifier: NCT00384527.
Musher
Daniel M
DM
Infectious Disease Section, The Medical Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, USA. daniel.musher@med.va.gov
Logan
Nancy
N
Bressler
Adam M
AM
Johnson
David P
DP
Rossignol
Jean-François
JF
D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects*; D004311:Double-Blind Method; D004761:Enterocolitis, Pseudomembranous / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009574:Nitro Compounds; D011446:Prospective Studies; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States; D014640:Vancomycin / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D009574:Nitro Compounds; D013844:Thiazoles; D014640:Vancomycin; C041747:nitazoxanide