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Published on: November 17, 2018
Nitazoxanide for the empiric treatment of pediatric infectious diarrhea
Jean-François Rossignol1, Nicolas Lopez-Chegne, Luis Martin Julcamoro
1Division of Gastroenterology & Hepatology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
Abstract:
We conducted a double-blind, placebo-controlled clinical trial to demonstrate the efficacy of nitazoxanide suspension for the treatment of presumed infectious diarrhea in children. Eligible patients must have had diarrheal illness lasting 3-29 days. Patients were randomized to receive either nitazoxanide or placebo twice daily for three days. The primary endpoint was time from first dose to resolution of symptoms. One hundred children mean age 3.3 years were enrolled. The median time to resolution of symptoms for nitazoxanide treated patients was 23 hours (IQR 4-48 hours) vs 103.5 hours (IQR 63->168 hours) for placebo (p<0.001). An analysis by disease subset indicated nitazoxanide treated patients had statistically shorter durations of diarrheal illness associated with Giardia lamblia (n=32, p<0.001) and those with no identified enteropathogen (n=38, p=0.008), when compared to placebo. The study medication was well tolerated. Overall, nitazoxanide was effective at reducing the duration of diarrheal illness associated with multiple etiologies, including patients with no identified enteropathogen. These results suggest nitazoxanide may be a viable therapeutic option for the empiric treatment of diarrheal illness in children where the etiology is unknown or presumed to be of infectious origin. Clinical trial registry number NCT01326338.
Insights
Nitazoxanide suspension significantly reduced diarrheal illness duration in children. This effective treatment option benefits patients with known or unknown infectious diarrhea causes.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Diarrheal illness is a common pediatric concern.
- Identifying the specific enteropathogen can be challenging.
- Effective empiric treatment options are needed for pediatric diarrhea.
Purpose of the Study:
- To evaluate the efficacy of nitazoxanide suspension in treating presumed infectious diarrhea in children.
- To compare the time to symptom resolution between nitazoxanide and placebo groups.
- To assess nitazoxanide's effectiveness across different diarrheal etiologies.
Main Methods:
- Double-blind, placebo-controlled clinical trial.
- 100 children (mean age 3.3 years) with diarrheal illness (3-29 days) were enrolled.
- Patients received nitazoxanide or placebo twice daily for three days.
Main Results:
- Nitazoxanide significantly reduced median time to symptom resolution (23 hours vs. 103.5 hours for placebo, p<0.001).
- Shorter illness durations were observed in nitazoxanide-treated patients with Giardia lamblia and those with no identified enteropathogen.
- Nitazoxanide was well-tolerated by study participants.
Conclusions:
- Nitazoxanide suspension is effective in reducing the duration of infectious diarrhea in children.
- The drug shows efficacy across various etiologies, including cases with unidentified pathogens.
- Nitazoxanide presents a viable option for the empiric treatment of pediatric diarrheal illness.
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