Status:
COMPLETED
Study of Nitazoxanide in the Treatment of Amebiasis in Children
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Amebiasis
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00366730
Start Date
February 1 2004
End Date
November 1 2005
Last Update
August 21 2006
Active Locations (2)
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1
University Hospital
Alexandria, Egypt
2
Benha University Hospital
Banhā, Egypt