Nitazoxanide in the treatment of viral gastroenteritis: a randomized double-blind placebo-controlled clinical trial.
BACKGROUND
Enteric viruses including noroviruses and rotavirus are leading causes of diarrhoeal disease and gastroenteritis worldwide, and there is no effective treatment.


OBJECTIVE
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.
Rossignol
J-F
JF
The Romark Institute for Medical Research, Tampa, FL 33607, USA. jrossignol@romark.com
El-Gohary
Y M
YM
D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D003967:Diarrhea / Q000821:virology; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008875:Middle Aged; D009574:Nitro Compounds; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D014777:Virus Diseases / Q000188:drug therapy*
D000890:Anti-Infective Agents; D009574:Nitro Compounds; D013844:Thiazoles; C041747:nitazoxanide