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Treatment of Asymptomatic Toxocariasis With Albendazole in Children

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ClinicalTrials.gov Identifier: NCT00755560
Recruitment Status : Unknown
Verified February 2016 by Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2008
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires

Study Description
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arms and Interventions
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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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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
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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    Key Record Dates
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