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Background & Aims: The aim of this study was to evaluate the efficacy of nitazoxanide for the treatment of diarrhea and enteritis caused by Cryptosporidium species in patients 12 years of age and older., Methods: A multicenter, randomized, double-blind, placebo-controlled study was conducted in 90 outpatients 12 years of age and older from the Nile Delta region of Egypt. Patients were randomized to receive either one 500 mg tablet or one matching placebo tablet, or 25 mL of nitazoxanide oral suspension (500 mg nitazoxanide), each given twice daily for 3 days. Clinical and microbiologic response rates were evaluated 4 days after completion of treatment., Results: Twenty-seven (96%) of the 28 patients receiving nitazoxanide tablets responded clinically compared with 11 (41%) of 27 patients who received placebo (P < .0001). Twenty-six (93%) of the 28 patients who received nitazoxanide were free of Cryptosporidium oocysts in each of 2 posttreatment stool samples compared with only 10 (37%) of 27 patients who received placebo (P < .0001). Response rates in patients receiving the tablets and the suspension were comparable (clinical response rate for suspension, 27 of 31 [87%]; microbiologic response rate for suspension, 28 of 31 [90%])., Conclusions: These findings show that a 3-day course of nitazoxanide is effective in treating diarrhea and enteritis caused by Cryptosporidium in nonimmunodeficient patients 12 years of age and older.

Background Enteric viruses including noroviruses and rotavirus are leading causes of diarrhoeal disease and gastroenteritis worldwide, and there is no effective treatment. Aim To evaluate nitazoxanide, a thiazolide anti-infective agent, in treating viral gastroenteritis in adults and adolescents. Methods 50 out-patients at least 12 years of age (mean 33.5 years) presenting with diarrhoea and stool-positive by enzyme-linked immunosorbent assay for norovirus, rotavirus or adenovirus were enrolled in a double-blind, placebo-controlled clinical trial. Patients were randomly assigned either nitazoxanide 500 mg or placebo twice daily for 3 days. The primary end point was time from first dose to resolution of symptoms. Analysis was modified intent-to-treat for 45 patients, excluding five patients with other identified enteropathogens at baseline. Results The median time from first dose to resolution of symptoms was 1.5 days (IQR: 0.5–2.5) for nitazoxanide-treated patients and 2.5 days (IQR: 1.5–4.5) for the placebo group. Significant reductions in time to resolution of symptoms were observed for all patients analysed ( P < 0.0001) and for subsets of patients with rotavirus ( P = 0.0052) and norovirus ( P = 0.0295). The number of patients with adenovirus ( n = 5) was too small to draw any conclusion. No significant adverse events were reported. Conclusions Nitazoxanide may play an important role in managing viral gastroenteritis in adults. [ABSTRACT FROM AUTHOR]