Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	September 2008
Actual Primary Completion Date :	July 2015
Estimated Study Completion Date :	July 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. Mean absolute reduction in eosinophil count from baseline [ Time Frame: 12 months after treatment ]

Secondary Outcome Measures :

1. Reduction in eosinophil count in more than 60% from baseline [ Time Frame: 1 year ]
2. Incidence of adverse drug events [ Time Frame: 3, 6, 9 and 12 months after treatment ]
3. Mean absolute reduction in eosinophil count [ Time Frame: 3, 6, 9 months after treatment ]

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Argentina
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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Jaime Altcheh, Service Head, Parasitology and Chagas Service, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:	NCT00755560 History of Changes
Other Study ID Numbers:	TOXOCARA-ALBENDAZOLE
First Posted:	September 19, 2008
Last Update Posted:	February 19, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires:

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

Additional relevant MeSH terms:

Toxocariasis; Helminthiasis, Animal; Helminthiasis; Parasitic Diseases; Ascaridida Infections; Secernentea Infections; Nematode Infections; Parasitic Diseases, Animal; Albendazole; Anthelmintics	Antiparasitic Agents; Anti-Infective Agents; Anticestodal Agents; Antiplatyhelmintic Agents; Antiprotozoal Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents