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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Toxocariasis | Drug: Albendazole Drug: Placebo | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Albendazole
Albendazole 10 - 15 mg/kg/day BID for 15 days
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Drug: Albendazole
Albendazole 10 - 15 mg/kg/day BID for 15 days
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Placebo Comparator: Placebo
Placebo BID for 15 days
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Drug: Placebo
Placebo BID for 15 days
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- Mean absolute reduction in eosinophil count from baseline [ Time Frame: 12 months after treatment ]
- 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 ]

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Ages Eligible for Study: | 2 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Argentina | |
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires | |
Buenos Aires, Argentina, 1425 |
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 |
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 |