Study of Nitazoxanide in the Treatment of Amebiasis in Children

Romark Laboratories

Status and phase

Completed

Phase 3

Conditions

Amebiasis

Treatments

Drug: Nitazoxanide

Study type

Interventional

Funder types

Industry

Identifiers

RM02-3014

Details and patient eligibility

About

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

Sex

All

Ages

1 to 11 years old

Volunteers

No Healthy Volunteers

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.