Snapshots for September 2006

Abstract

Musher et al 1 reported the results of a prospective, randomized, double-blind study comparing nitazoxanide with metronidazole in treating hospitalized patients with Clostridium difficile colitis. The study was conducted at 7 medical centers in the United States and included patients older than 18 years with diarrhea (defined as >3 unformed stools within in a 24-hour period), an enzyme immunoassay result positive for C. difficile toxin, and 1 or more of the following findings: fever,, abdominal pain. or leukocytosis. The patients were randomized to 1 of 3 treatment groups including (1) metronidazole 250 mg orally every 6 hours for 10 days, (2) nitazoxanide 500 mg orally every 12 hours for 7 days, and (3) nitazoxanide 500 mg orally every 12 hours for 10 days. The primary analysis included 34 patients in the metronidazole group, 40 patients in the 7-day-therapy nitazoxanide group and 36 patients in the 10-day-therapy nitazoxanide group. The primary end point of the study was clinical response after 7 days of treatment and defined as the return to healthy bowel habits and no other clinical findings attributable to C. difficile infection. The demographic data were similar between the treatment groups. Clinical response occurred in 28 (82.4%) of the 34 patients who received metronidazole compared with 36 (90.0%) of the 40 patients in the 7-day-therapy nitazoxanide group and 32 (88.9%) of the 36 patients in the 10-day-therapy nitazoxanide group (difference, 7.1%; 95% confidence interval, -7.1% to 25.5%). Sustained response, 31 days after beginning treatment, was reported in 19 (57.6%) of the 33 patients who received metronidazole compared with 25 (65.8%) of the 38 patients randomized to the 7-day-therapy nitazoxanide group and 26 (74.3%) of the 35 patients randomized to the 10-day-therapy nitazoxanide group (P = 0.34). The overall 31 -day mortality rate in the study was 9.1%.