Study of Nitazoxanide in the Treatment of Amebiasis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-11-30

Brief Summary

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

Detailed Description

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Conditions

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Amebiasis

Keywords

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Amebiasis Entamoeba histolytica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nitazoxanide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Samir M Kabil, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Yehia El-Gohary, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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University Hospital

Alexandria, , Egypt

Site Status

Benha University Hospital

Banhā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RM02-3014

Identifier Type: -

Identifier Source: org_study_id