Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Phase 3

Active, not recruiting

• Conditions: Toxocariasis
• Interventions: Drug: Placebo; Drug: Albendazole

• Registration Number: NCT00755560
• Lead Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Primary Completion: 2015-07
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo BID for 15 days
Albendazole	Albendazole	Albendazole 10 - 15 mg/kg/day BID for 15 days

Primary Outcome Measures

Name	Time	Method
Mean absolute reduction in eosinophil count from baseline	12 months after treatment

Secondary Outcome Measures

Name	Time	Method
Reduction in eosinophil count in more than 60% from baseline	1 year
Mean absolute reduction in eosinophil count	3, 6, 9 months after treatment
Incidence of adverse drug events	3, 6, 9 and 12 months after treatment

Trial Locations

Locations (1)

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires; 🇦🇷 Buenos Aires, Argentina