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Treatment of Asymptomatic Toxocariasis With Albendazole in Children

This study is currently recruiting participants.
Verified March 2012 by Hospital de Niños R. Gutierrez de Buenos Aires
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
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
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
Helminthiasis, Animal
Helminthiasis
Ascaridida Infections
Secernentea Infections
Nematode Infections
Albendazole
Anticestodal Agents
Antiplatyhelmintic Agents
 Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013