NCT00366730

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
Last Updated

August 21, 2006

Status Verified

August 1, 2006

First QC Date

August 18, 2006

Last Update Submit

August 18, 2006

Conditions

Amebiasis

Keywords

AmebiasisEntamoeba histolytica

Outcome Measures

Primary Outcomes (1)

  • Resolution of clinical symptoms of amebiasis

Secondary Outcomes (2)

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

  • Time from initiation of treatment to passage of last unformed stool

Interventions

NitazoxanideDRUG

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Alexandria, Egypt

Location

Benha University Hospital

Banhā, Egypt

Location

MeSH Terms

Conditions

Amebiasis

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfections

Study Officials

  • Samir M Kabil, MD

    Benha University

    PRINCIPAL INVESTIGATOR

  • Yehia El-Gohary, MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 21, 2006

Study Start

February 1, 2004

Study Completion

November 1, 2005

Last Updated

August 21, 2006

Record last verified: 2006-08

Locations

EG(2)