Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Hospital de Niños R. Gutierrez de Buenos Aires45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Toxocariasis

Interventions

AlbendazoleDRUG

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

PlaceboDRUG

Placebo BID for 15 days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Mean absolute reduction in eosinophil count from baseline

Time frame: 12 months after treatment

Secondary Outcomes

Reduction in eosinophil count in more than 60% from baseline

Time frame: 1 year

Incidence of adverse drug events

Time frame: 3, 6, 9 and 12 months after treatment

Mean absolute reduction in eosinophil count

Time frame: 3, 6, 9 months after treatment

Data from ClinicalTrials.gov

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