Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Brief Title

Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Official Title

Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial

Brief Summary

      The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the
      asymptomatic infection with the parasite Toxocara in children. Treatment response is defined
      as a reduction in the number of eosinophils in blood. The study drug will be compared to
      placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50
      children (25 per group) will be enrolled in the study.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Mean absolute reduction in eosinophil count from baseline

Secondary Outcome

 Reduction in eosinophil count in more than 60% from baseline

Condition

Toxocariasis

Intervention

Albendazole

Study Arms / Comparison Groups

 Albendazole
Description:  Albendazole 10 - 15 mg/kg/day BID for 15 days

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

September 2008

Completion Date

July 2017

Primary Completion Date

July 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Pediatric ambulatory patients with asymptomatic toxocariasis

          -  Children 2 - 15 years old

          -  Absolute eosinophil count > 1100 / mm3

          -  Normal ophthalmoscopy

        Exclusion Criteria:

          -  Treatment with a benzimidazole in the previous year

          -  Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis,
             uncinarias, Trichuris trichuria)

          -  Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly,
             ocular compromise due to toxocara)

          -  Concomitant diseases

          -  Immunocompromised patients

          -  Altered liver or kidney function

          -  Pregnancy
      

Gender

All

Ages

2 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Jaime Altcheh, MD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00755560

Organization ID

TOXOCARA-ALBENDAZOLE


Responsible Party

Principal Investigator

Study Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Collaborators

 The Hospital for Sick Children

Study Sponsor

Jaime Altcheh, MD, Study Chair, Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires


Verification Date

February 2016