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

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.

2008-09-01

2015-07-01

2025-07-01

Active (not recruiting)

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

2023-03-02