Study of Nitazoxanide in the Treatment of Amebiasis in Children

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Nitazoxanide

About this trial

This is an interventional treatment trial for Amebiasis focused on measuring Amebiasis, Entamoeba histolytica

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

University Hospital
Benha University Hospital

Outcomes

Primary Outcome Measures

Resolution of clinical symptoms of amebiasis

Secondary Outcome Measures

Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples

Time from initiation of treatment to passage of last unformed stool

Full Information

NCT ID

NCT00366730

First Posted

August 18, 2006

Last Updated

August 18, 2006

Sponsor

Romark Laboratories L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00366730

Brief Title

Study of Nitazoxanide in the Treatment of Amebiasis in Children

Official Title

Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Romark Laboratories L.C.

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amebiasis

Keywords

Amebiasis, Entamoeba histolytica

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Primary Outcome Measure Information:

Title

Resolution of clinical symptoms of amebiasis

Secondary Outcome Measure Information:

Title

Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples

Title

Time from initiation of treatment to passage of last unformed stool

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir M Kabil, MD

Organizational Affiliation

Benha University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yehia El-Gohary, MD

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Alexandria

Country

Egypt

Facility Name

Benha University Hospital

City

Benha

Country

Egypt

Amebiasis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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