Study of Nitazoxanide in the Treatment of Amebiasis in Children

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

Criteria

Inclusion Criteria:

• Age 1 to 11 years.

• Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.

• Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

• Patients with identified causes of diarrhea other than E. histolytica.

• Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.

• Females who are pregnant, suspected of being pregnant or breastfeeding.

• Serious systemic disorders incompatible with the study.

• History of hypersensitivity to nitazoxanide.

• Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.

• Patients with amebic liver abscess.

• Patients known to have or suspected of having AIDS.

• Patient with immune deficiencies.