Study of Nitazoxanide in the Treatment of Amebiasis in Children

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

Brief Summary

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


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Resolution of clinical symptoms of amebiasis

Secondary Outcome

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

Condition

Amebiasis

Intervention

Nitazoxanide


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

February 2004

Completion Date

November 2005


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.
      

Gender

All

Ages

1 Year - 11 Years

Accepts Healthy Volunteers

No

Contacts

Samir M Kabil, MD, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT00366730

Organization ID

RM02-3014



Study Sponsor

Romark Laboratories L.C.


Study Sponsor

Samir M Kabil, MD, Principal Investigator, Benha University


Verification Date

August 2006