Study of Nitazoxanide in the Treatment of Amebiasis in Children
Phase 3
Completed
- Conditions
- Amebiasis
- Registration Number
- NCT00366730
- Lead Sponsor
- Romark Laboratories L.C.
- Brief Summary
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Resolution of clinical symptoms of amebiasis
- Secondary Outcome Measures
Name Time Method Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples Time from initiation of treatment to passage of last unformed stool
Trial Locations
- Locations (2)
Benha University Hospital
🇪🇬Benha, Egypt
University Hospital
🇪🇬Alexandria, Egypt