This trial is active, not recruiting.

Condition toxocariasis
Treatments albendazole, placebo
Phase phase 3
Sponsor Hospital de Niños R. Gutierrez de Buenos Aires
Collaborator The Hospital for Sick Children
Start date September 2008
End date July 2015
Trial size 50 participants
Trial identifier NCT00755560, TOXOCARA-ALBENDAZOLE


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Albendazole 10 - 15 mg/kg/day BID for 15 days
Albendazole 10 - 15 mg/kg/day BID for 15 days
(Placebo Comparator)
Placebo BID for 15 days
Placebo BID for 15 days

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

Eligibility Criteria

Male or female participants from 2 years up to 15 years old.

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

Additional Information

Official title Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial
Principal investigator Hector Freilij, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hospital de Niños R. Gutierrez de Buenos Aires.