Treatment of Asymptomatic Toxocariasis With Albendazole in Children

NCT ID: NCT00755560

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Toxocariasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Albendazole

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

Group Type ACTIVE_COMPARATOR

Albendazole

Intervention Type DRUG

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

Placebo

Placebo BID for 15 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID for 15 days

Interventions

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Albendazole

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

Intervention Type DRUG

Placebo

Placebo BID for 15 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de NiƱos R. Gutierrez de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Dr Jaime Altcheh

Service Head, Parasitology and Chagas Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Altcheh, MD

Role: STUDY_CHAIR

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

Hector Freilij, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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TOXOCARA-ALBENDAZOLE

Identifier Type: -

Identifier Source: org_study_id

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