Treatment of Asymptomatic Toxocariasis With Albendazole in Children

This study is currently recruiting participants.

Verified by Hospital de Niños R. Gutierrez de Buenos Aires, August 2009

First Received: September 17, 2008 Last Updated: August 3, 2009 History of Changes

Sponsor:	Hospital de Niños R. Gutierrez de Buenos Aires
Collaborator:	The Hospital for Sick Children
Information provided by:	Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:	NCT00755560

Purpose

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	Intervention	Phase
Asymptomatic Toxocariasis	Drug: Albendazole Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial

Resource links provided by NLM:

Drug Information available for: Albendazole

U.S. FDA Resources

Further study details as provided by Hospital de Niños R. Gutierrez de Buenos Aires:

Primary Outcome Measures:

Mean absolute reduction in eosinophil count from baseline [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in eosinophil count in more than 60% from baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of adverse drug events [ Time Frame: 3, 6, 9 and 12 months after treatment ] [ Designated as safety issue: Yes ]
Mean absolute reduction in eosinophil count [ Time Frame: 3, 6, 9 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Albendazole: Active Comparator Albendazole 10 - 15 mg/kg/day BID for 15 days	Drug: Albendazole Albendazole 10 - 15 mg/kg/day BID for 15 days
Placebo: Placebo Comparator Placebo BID for 15 days	Drug: Placebo Placebo BID for 15 days

Eligibility

Ages Eligible for Study:	2 Years to 15 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755560

Contacts

Contact: Jaime Altcheh, MD

54-11-4964-3093

jaltcheh@intramed.net

Locations

Argentina
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires	Recruiting
Buenos Aires, Argentina, 1425
Contact: Jaime Altcheh, MD 54-11-4964-3093 jaltcheh@intramed.net
Principal Investigator: Jaime Altcheh, MD
Principal Investigator: Hector Freilij, MD
Sub-Investigator: Guillermo Drelichman, MD
Sub-Investigator: Facundo Garcia Bournissen, MD

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

No publications provided

Responsible Party:	Servicio de Parasitología, Hospital de Niños "R Gutiérrez" de Buenos Aires ( Dr Jaime Altcheh )
Study ID Numbers:	TOXOCARA-ALBENDAZOLE
Study First Received:	September 17, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00755560 History of Changes
Health Authority:	Argentina: Human Research Bioethics Committee; Argentina: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital de Niños R. Gutierrez de Buenos Aires:

Toxocara
Pediatrics
Albendazole

eosinophilia
parasitology
pediatric clinical pharmacology

Additional relevant MeSH terms:

Ascaridida Infections
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiplatyhelmintic Agents
Mitosis Modulators
Nematode Infections
Anthelmintics
Antimitotic Agents
Pharmacologic Actions

Anticestodal Agents
Helminthiasis, Animal
Albendazole
Toxocariasis
Antiparasitic Agents
Therapeutic Uses
Tubulin Modulators
Parasitic Diseases
Parasitic Diseases, Animal
Helminthiasis
Secernentea Infections

ClinicalTrials.gov processed this record on February 08, 2010