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Active, not recruitingNCT00755560Updated Mar 2, 2023

Treatment of Asymptomatic Toxocariasis With Albendazole in Children

A Phase 3 interventional study of Albendazole and Placebo in Toxocariasis, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Active, not recruiting at 1 site in Argentina. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Toxocariasis

Keywords

  • Toxocara
  • Pediatrics
  • Albendazole
  • eosinophilia
  • parasitology
  • pediatric clinical pharmacology
03

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Albendazole

    Albendazole 10 - 15 mg/kg/day BID for 15 days

    Drug: Albendazole

  • Placebo comparator
    Placebo

    Placebo BID for 15 days

    Drug: Placebo

Interventions

  • DrugAlbendazole

    Albendazole 10 - 15 mg/kg/day BID for 15 days

  • DrugPlacebo

    Placebo BID for 15 days

05

What researchers measure

Primary outcomes

  1. Mean absolute reduction in eosinophil count from baseline

    Time frame: 12 months after treatment

Secondary outcomes

  1. Reduction in eosinophil count in more than 60% from baseline

    Time frame: 1 year

  2. Incidence of adverse drug events

    Time frame: 3, 6, 9 and 12 months after treatment

  3. Mean absolute reduction in eosinophil count

    Time frame: 3, 6, 9 months after treatment

06

Study locations

1 site
  • Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
    Buenos Aires, 1425, Argentina
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT00755560
Lead sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Responsible party
Dr Jaime Altcheh (Service Head, Parasitology and Chagas Service, Hospital de Niños R. Gutierrez de Buenos Aires) — Principal investigator
First posted
Sep 19, 2008
Start date
Sep 2008
Primary completion
Jul 2015
Completion
Jul 2025 (estimated)
Last update
Mar 2, 2023

Study contacts

Jaime Altcheh, MD
study chair · Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Hector Freilij, MD
principal investigator · Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Hospital de Niños R. Gutierrez de Buenos Aires

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