Treatment of Asymptomatic Toxocariasis With Albendazole in Children

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00755560

First Posted: September 19, 2008

Last Update Posted: February 19, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

The Hospital for Sick Children

Information provided by (Responsible Party):

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

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
Toxocariasis	Drug: Albendazole Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Albendazole

Genetic and Rare Diseases Information Center resources: Helminthiasis

U.S. FDA Resources

Further study details as provided by Dr Jaime Altcheh, 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 ]

Secondary Outcome Measures:

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


Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2017
Primary Completion Date:	July 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755560

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


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 Submitted:	September 17, 2008
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

To Top