Treatment of Asymptomatic Toxocariasis With Albendazole in Children

February 28, 2023 updated by: Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean absolute reduction in eosinophil count from baseline
Time Frame: 12 months after treatment
12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in eosinophil count in more than 60% from baseline
Time Frame: 1 year
1 year
Incidence of adverse drug events
Time Frame: 3, 6, 9 and 12 months after treatment
3, 6, 9 and 12 months after treatment
Mean absolute reduction in eosinophil count
Time Frame: 3, 6, 9 months after treatment
3, 6, 9 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2015

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOXOCARA-ALBENDAZOLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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