Clinical Question: Does nitazoxanide (Alinia) reduce the duration of rotavirus diarrhea in hospitalized children?
Setting: Inpatient (ward only)
Study Design: Randomized controlled trial (double-blinded)
Synopsis: This was a preliminary study of 38 Egyptian patients younger than 12 years with watery diarrhea severe enough to require hospitalization. All of these children had confirmed rotavirus infection. They were randomly assigned (concealed allocation) to receive three days of nitazoxanide or placebo. Most of the children had five to 10 or more stools per day. Most of the hospitalized children were malnourished and had nearly one week of symptoms before admission. The dosage of nitazoxanide was 200 mg twice daily for children four to 11 years of age; 100 mg twice daily for children 12 to 47 months of age; and 0.375 mg per kg twice daily for those younger than 12 months. All patients remained in the hospital for one week after the start of treatment.
The authors used an intention-to-treat analysis but removed children who also had other identified causes of diarrhea (e.g., bacterial pathogens,Giardia lamblia, Entamoeba histolytica). The children receiving nitazoxanide had a significant reduction in the duration of illness (31 compared with 75 hours in the control patients), although the authors do not define how this outcome was determined. The authors reported no significant adverse events in the treatment group and two minor adverse events in the control group.
Bottom Line: In this exploratory study, nitazoxanide reduced the duration of illness by nearly two days in children hospitalized with rotavirus diarrhea. It is unclear whether these findings would be similar in children who are less severely ill. (Level of evidence: 2b–)