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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 March 2023 |
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Main ID: |
NCT00755560 |
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Date of registration:
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17/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Asymptomatic Toxocariasis With Albendazole in Children
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Scientific title:
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Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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45 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT00755560 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Jaime Altcheh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires |
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Name:
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Hector Freilij, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Toxocariasis
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Intervention(s)
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Drug: Albendazole
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Drug: Placebo
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Primary Outcome(s)
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Mean absolute reduction in eosinophil count from baseline
[Time Frame: 12 months after treatment]
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Secondary Outcome(s)
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Reduction in eosinophil count in more than 60% from baseline
[Time Frame: 1 year]
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Incidence of adverse drug events
[Time Frame: 3, 6, 9 and 12 months after treatment]
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Mean absolute reduction in eosinophil count
[Time Frame: 3, 6, 9 months after treatment]
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Secondary ID(s)
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TOXOCARA-ALBENDAZOLE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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