Vancomycin vs. metronidazole for C. difficile colitis
Trial question
What is the effect of vancomycin in patients with C. difficile-associated diarrhea?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 150
150 patients (68 female, 82 male).
Inclusion criteria: patients with C. difficile-associated diarrhea were stratified according to whether they had mild or severe disease based on clinical criteria.
Key exclusion criteria: perforated viscus or bowel obstruction; prior failure of C. difficile-associated diarrhea to respond to either study drug; pregnancy; history of allergy to either study drug; or treatment with oral vancomycin or parenteral or oral metronidazole during the previous 14 days.
Interventions
N=71 vancomycin (125 mg QID PO for 10 days).
N=79 metronidazole (250 mg QID PO for 10 days).
Primary outcome
Cure rate
97%
84%
97.0 %
72.8 %
48.5 %
24.3 %
0.0 %
Vancomycin
Metronidazole
Significant
increase ▲
NNT = 7
Significant increase in cure rate (97% vs. 84%; RR 1.15, 95% CI 0.33 to 1.97).
Secondary outcomes
No significant difference in cure in patients with mild disease (98% vs. 90%; RR 1.09, 95% CI -1.22 to 3.4).
Significant increase in cure in patients with severe disease (97% vs. 76%; RR 1.28, 95% CI 0.2 to 2.36).
Conclusion
In patients with C. difficile-associated diarrhea were stratified according to whether they had mild or severe disease based on clinical criteria, vancomycin was superior to metronidazole with respect to cure rate.
Reference
Zar FA, Bakkanagari SR, Moorthi KM et al. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis. 2007 Aug 1;45(3):302-7.
Open reference URL