The Effectiveness of Albendazole Treatment Among Infected Toxocara Children

NCT05208333 | Unknown DMC

• 1 other identifier: 2021020107KHCN
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study consists 2 phases. The first phase will conduct a cross-sectional study to determine the infection rate of Toxocariasis larvae, describe the clinical and paraclinical characteristics, identify risk factors related to Toxocariasis larva infection. The second phase will conduct an interventional study to evaluate the effectiveness and factors related to the Albendazole treatment on pupils infected with Toxocariasis larvae in Ho Chi Minh City.

Conditions

Toxocara Infection

Keywords

Toxocara; infection; children; Ho Chi Minh City; Albendazole; treatment; intervention; pupils

Outcome Measures

Primary Outcomes (1)

• Procedures Guidelines for diagnosis, treatment, and post-treatment follow-up of Toxocariasis larvae

  After phase 1, we hope that we can draw a new procedure guideline for the diagnosis and treatment. And after this study is done, the new standard of guidelines for treatment of Toxocariasis infection can be applied for all children hospital in Vietnam.

  12 months

Secondary Outcomes (3)

• Seminars on treatment and follow-up after treatment of toxocariasis

  12 months

• Pet care consultation club, how to prevent toxocariasis

  12 months

• Publishing journal articles

  24 months

Study Arms (1)

Albendazole treatment

OTHER

Treatment drugs: Albendazole (Zentel) tablets 200mg, Glaxo Wellcome Production France manufacturer . Dose: 15 mg/kg divided into 2 times/day x 5 days, orally after meals. Procedure: Distributing albedazol (Zentel) 200mg at school to parents or guardians, dose 15mg/kg divided into 2 times/day, instructions to take the medicine in full dose, at the right time after meals, for 5 days. Limiting reinfection: Advice on preventing reinfection Advice on preventing re-infection according to Vietnam Ministry of Health disease prevention guidelines

Drug: Albenza 200Mg Tablet

Interventions

Albenza 200Mg Tablet DRUG

Distributing albedazol (Zentel) 200mg at school to parents or guardians, dose 15mg/kg divided into 2 times/day, instructions to take the medicine in full dose, at the right time after meals, for 5 days. Limiting reinfection: Advice on preventing reinfection

Also known as: Zentel

Albendazole treatment

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pupils aged 3-15 years from Kindergarten to Secondary schools
• Agreement from parents with writen informed consent
• Children infected with toxocariasis may have symptoms and the ELISA test is positive for Toxocariasis larvae, with or without increased BCAT and IgE.
• ELISA results according to the specified Kit and read according to optical densities (OD).
• Cases of suspected heart, lung, liver, eye damage ... referred to Children's Hospital 2 for examination by specialty and not for intervention.

You may not qualify if:

• Children aged 3-15 years without writen informed consent from parents and themselves.
• Children infected with Toxocariasis larvae which are not common type.
• Children infected with Toxocariasis are suffering from acute diseases or other chronic diseases: Cardiovascular, hepatitis, kidney, stomach, mental, or suspected tumor...
• Children with a history of hypersensitivity to any ingredient in the treatment of Albendazole.
• Infected children do not have enough follow-up process before and after 1, 6 months of treatment.

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead
• Department of Science and Technology, Ho Chi Minh City, Viet Nam: collaborator

Related Publications (1)

• Ha TV, Tang HK, Ngo BV, Le TPT, Le DH, Tran YML, Dang DKH, Vo TTN. Clinical and laboratory characteristics of Toxocara canis infection among children in Ho Chi Minh City, Vietnam. Trans R Soc Trop Med Hyg. 2025 Jan 3;119(1):27-32. doi: 10.1093/trstmh/trae057.

  PMID: 39253804 DERIVED

MeSH Terms

Conditions

Toxocariasis; Infections

Interventions

Albendazole; Tablets

Condition Hierarchy (Ancestors)

Helminthiasis, Animal; Helminthiasis; Parasitic Diseases; Ascaridida Infections; Secernentea Infections; Nematode Infections; Parasitic Diseases, Animal; Animal Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Lan Anh T Do, PhD

CONTACT

+84945217146; anhdtl@pnt.edu.vn

Duc H Le, MD

CONTACT

+84981799674; duclh@pnt.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Pediatrics (Pham Ngoc Thach University of Medicine), Principal Investigator, Clinical doctor at Children Hospital 2 Ho Chi Minh city, PhD

Model Details: We conducted a cross-sectional study among 960 pupils aged 3-15 years from Kindergartens, primary schools and secondary schools to describe the characracteristics, and determine the factors related to Toxocariasis infection. After that, we identified infected children from 960 children, we choose 146 infected children who are as sampling for intervention with treatment of Albendazole. Then, we evaluate the effectiveness of Albendazole treatment by follow-up these 146 infected children for 6 months.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 26, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share