Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Toxocariasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00755560
• Other study ID #: TOXOCARA-ALBENDAZOLE
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: July 2025
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Toxocariasis

Intervention

Drug:
• Albendazole
Albendazole 10 - 15 mg/kg/day BID for 15 days
• Placebo
Placebo BID for 15 days

Locations

Country	Name	City	State
Argentina	Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute reduction in eosinophil count from baseline		12 months after treatment
Secondary	Reduction in eosinophil count in more than 60% from baseline		1 year
Secondary	Incidence of adverse drug events		3, 6, 9 and 12 months after treatment
Secondary	Mean absolute reduction in eosinophil count		3, 6, 9 months after treatment