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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

September 17, 2008
March 9, 2012
September 2008
July 2012   (final data collection date for primary outcome measure)
Mean absolute reduction in eosinophil count from baseline [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00755560 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Asymptomatic Toxocariasis With Albendazole in Children
Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asymptomatic Toxocariasis
  • Drug: Albendazole
    Albendazole 10 - 15 mg/kg/day BID for 15 days
  • Drug: Placebo
    Placebo BID for 15 days
  • Active Comparator: Albendazole
    Albendazole 10 - 15 mg/kg/day BID for 15 days
    Intervention: Drug: Albendazole
  • Placebo Comparator: Placebo
    Placebo BID for 15 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 15 Years
No
Contact: Jaime Altcheh, MD 54-11-4964-3093 jaltcheh@gmail.com
Argentina
 
NCT00755560
TOXOCARA-ALBENDAZOLE
Yes
Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires
Hospital de Niños R. Gutierrez de Buenos Aires
The Hospital for Sick Children
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
Hospital de Niños R. Gutierrez de Buenos Aires
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP