Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires (Other)

Overall Status

Unknown status

CT.gov ID

NCT00755560

Collaborator

The Hospital for Sick Children (Other)

Enrollment

Location

Arms

106

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Toxocariasis	Drug: Albendazole Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albendazole Albendazole 10 - 15 mg/kg/day BID for 15 days	Drug: Albendazole Albendazole 10 - 15 mg/kg/day BID for 15 days
Placebo Comparator: Placebo Placebo BID for 15 days	Drug: Placebo Placebo BID for 15 days

Arm

Intervention/Treatment

Active Comparator: Albendazole

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

Drug: Albendazole

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

Placebo Comparator: Placebo

Placebo BID for 15 days

Drug: Placebo

Placebo BID for 15 days

Outcome Measures

Primary Outcome Measures

Mean absolute reduction in eosinophil count from baseline [12 months after treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Buenos Aires		Argentina	1425

Sponsors and Collaborators

Hospital de Niños R. Gutierrez de Buenos Aires
The Hospital for Sick Children

Investigators

Study Chair: Jaime Altcheh, MD, Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Principal Investigator: Hector Freilij, MD, Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires