Treatment of Asymptomatic Toxocariasis With Albendazole in Children

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2012 by Hospital de Niños R. Gutierrez de Buenos Aires.
Recruitment status was Recruiting

Sponsor:

Collaborator:

The Hospital for Sick Children

Information provided by (Responsible Party):

Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires

ClinicalTrials.gov Identifier:

NCT00755560

First received: September 17, 2008

Last updated: March 9, 2012

Last verified: March 2012

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Genetic and Rare Diseases Information Center resources: Helminthiasis Toxocariasis

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:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Jaime Altcheh, MD	54-11-4964-3093	jaltcheh@gmail.com

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: Facundo Garcia Bournissen, MD
Sub-Investigator: Samanta Moroni, MD
Sub-Investigator: Guillermo Moscatelli, 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:	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
Study First Received:	September 17, 2008
Last Updated:	March 9, 2012
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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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