Treatment of Asymptomatic Toxocariasis With Albendazole in Children

NCT00755560 | Unknown Phase 3 DMC

• 1 other identifier: TOXOCARA-ALBENDAZOLE
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxocariasis

Keywords

Toxocara; Pediatrics; Albendazole; eosinophilia; parasitology; pediatric clinical pharmacology

Outcome Measures

Primary Outcomes (1)

• Mean absolute reduction in eosinophil count from baseline

  12 months after treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Albendazole

ACTIVE COMPARATOR

Albendazole 10 - 15 mg/kg/day BID for 15 days

Drug: Albendazole

Placebo

PLACEBO COMPARATOR

Placebo BID for 15 days

Drug: Placebo

Interventions

Albendazole DRUG

Albendazole 10 - 15 mg/kg/day BID for 15 days

Albendazole

Placebo DRUG

Placebo BID for 15 days

Placebo

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric ambulatory patients with asymptomatic toxocariasis
• Children 2 - 15 years old
• Absolute eosinophil count \> 1100 / mm3
• Normal ophthalmoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Buenos Aires, 1425, Argentina

Location

MeSH Terms

Conditions

Toxocariasis; Eosinophilia

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Helminthiasis, Animal; Helminthiasis; Parasitic Diseases; Infections; Ascaridida Infections; Secernentea Infections; Nematode Infections; Parasitic Diseases, Animal; Animal Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jaime Altcheh, MD

  Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

  STUDY CHAIR

• Hector Freilij, MD

  Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Service Head, Parasitology and Chagas Service

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

AR (1)