Treatment of Asymptomatic Toxocariasis With Albendazole in Children
This study is ongoing, but not recruiting participants.
Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
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: February 18, 2016
Last verified: February 2016
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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 |
|---|---|---|
|
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:
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 2017 |
| Primary Completion Date: | July 2015 (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 (Child) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755560
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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: | February 18, 2016 |
| Health Authority: | Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 29, 2016