Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Hospital de Niños R. Gutierrez de Buenos Aires

Status and phase: Active, not recruiting; Phase 3

Conditions: Toxocariasis

Treatments: Drug: Placebo; Drug: Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00755560

TOXOCARA-ALBENDAZOLE

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Albendazole

Active Comparator group

Description:

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

Treatment:

Drug: Albendazole

Placebo

Placebo Comparator group

Description:

Placebo BID for 15 days

Treatment:

Drug: Placebo