Treatment of Asymptomatic Toxocariasis With Albendazole in Children

Condition(s) targeted: Asymptomatic Toxocariasis

Intervention: Albendazole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hospital de Niños R. Gutierrez de Buenos Aires

Official(s) and/or principal investigator(s):
Jaime Altcheh, MD, Study Chair, Affiliation: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Hector Freilij, MD, Principal Investigator, Affiliation: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Overall contact:
Jaime Altcheh, MD, Phone: 54-11-4964-3093, Email: jaltcheh@intramed.net

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.

Official title: Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Mean absolute reduction in eosinophil count from baseline

Secondary outcome:

Reduction in eosinophil count in more than 60% from baseline

Incidence of adverse drug events

Mean absolute reduction in eosinophil count

Minimum age: 2 Years. Maximum age: 15 Years. Gender(s): Both.

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

Jaime Altcheh, MD, Phone: 54-11-4964-3093, Email: jaltcheh@intramed.net

Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires, Buenos Aires 1425, Argentina; Recruiting
Jaime Altcheh, MD, Phone: 54-11-4964-3093, Email: jaltcheh@intramed.net
Jaime Altcheh, MD, Principal Investigator
Hector Freilij, MD, Principal Investigator
Guillermo Drelichman, MD, Sub-Investigator
Facundo Garcia Bournissen, MD, Sub-Investigator

Starting date: September 2008
Ending date: December 2011
Last updated: August 3, 2009