Nitazoxanide in Acute Rotavirus Diarrhea- A Randomized Controlled Trial Study in a Tertiary Care Hospital in Bangladesh

Background: Acute rotavirus diarrhea is one of the leading cause of morbidity and mortality in children younger than 5 years. Nitazoxanide, an antiparasitic agent, acts by inhibiting the maturation of rotavirus viral protein 7 thus interferes with viral morphogenesis. Aim of the study: was to evaluate the role of nitazoxanide in the treatment of acute rotavirus diarrhea in 6 months to 2 years aged children. Methods: This randomized controlled trial was conducted at Bangladesh Shishu Hospital & Institute, Dhaka, Bangladesh from June 2018 to July 2020. A total of 70 children with acute onset diarrhea of <48 hours. duration was included in this study. All the studied patients were divided into two equal groups (group I and group II) by lottery, each comprising 35 children. The groupI represented the study group who received standard treatment of diarrhea plus oral nitazoxanide (15mg/kg/day) twice daily for 3 days and the group II is the control group received standard treatment only. Results: Study demonstrated that maximum number of patients 22 (31.4%) were between 14-17 months of age group and 36% patients came from rural, 64% from urban areas. Study showed before commencement of treatment most of the patients in both groups experienced some dehydration, vomiting, fever, & abdominal distension. At 48 hours’ improvement was observed in both groups, comparatively higher in group I. Difference of some dehydration and vomiting improvement between two groups were statistically significant (p <0.05). After 3 days’ treatment normal stool consistency was found in 24(68.5%) patients in group I & 10 (28.5%) in group II patients. The difference was also statistically significant (p=<0.05). Mean time of resolution of diarrhea 62.5 hours in Group-I and 96.5 hours in group-II. Compared to the group II, group I showed decrease in mean time of resolution of diarrhea (p= 0.001). The mean duration of hospital stay was prolonged in group-II (86.5 hours vs. 102.5 hours in group I & II respectively), the difference was statistically significant (p˂0.05). Conclusion: In the present study, oral nitazoxanide was found effective in the treatment of acute rotavirus diarrhea in 6 months to 2 years old children.