Toxocariasis
Conditions
Keywords
Toxocara, Pediatrics, Albendazole, eosinophilia, parasitology, pediatric clinical pharmacology
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.
Interventions
DRUGAlbendazole
Albendazole 10 - 15 mg/kg/day BID for 15 days
DRUGPlacebo
Placebo BID for 15 days
Sponsors
Hospital de Niños R. Gutierrez de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute reduction in eosinophil count from baseline | 12 months after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in eosinophil count in more than 60% from baseline | 1 year |
| Incidence of adverse drug events | 3, 6, 9 and 12 months after treatment |
| Mean absolute reduction in eosinophil count | 3, 6, 9 months after treatment |
Countries
Argentina
Outcome results
None listed