Research on the Situation of Toxacara Infection and the Effectiveness of Albendazole Treatment Among Pupils Aged 3-15 Years in Ho Chi Minh City
试验速览
- 阶段
- 不适用
- 入组人数
- 960
- 主要终点
- Procedures Guidelines for diagnosis, treatment, and post-treatment follow-up of Toxocariasis larvae
研究概览
简要总结
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.
详细描述
This study includes 2 phases below:
Phase 1: Cross-sectional study Sample population: total 960 pupils aged 3-15 years old from public kindergartens, primary schools, and secondary schools in Ho Chi Minh City.
Data collection will be conducted following stages below:
- Explain counseling to parents/guardians and explain to children (for children > 9 years old) about Toxocariasis in dogs/cats, procedures for examination, testing, medication and follow-up. Clearly explain the benefits as well as the possible risks of participating in the study. If agreeing to participate, the parent/guardian and the child (over 9 years old) sign the commitment through a consent form.
- Clinical examination by doctors of Pediatrics, Pham Ngoc Thach University of Medicine, seniority, prestige, practice certificates, undergraduate and postgraduate teaching at the hospital Children 2.
- Fill in the data collection questionnaire
- Taking blood for testing:
- Type of test: Complete blood count (TPTTBM), AST, ALT, Urea, Creatinine, IgE, ELISA.
- Place of implementation: At the school of the child selected for the study.
- Performer: Senior and skilled pediatric nurse working at Children's Hospital 2, with good practice and professional certificates
- Blood volume taken: 4ml (0.5ml for BM; 1.5ml for urea, creatinine, AST, ALT, IgE; 2ml for ELISA).
- Preserve and transport blood samples to the laboratory of Children's Hospital 2 according to the procedure.
- Treatment of accidents, if any, during the procedure: Equip shock-proof boxes and appropriate on-site first aid tools, treat them according to the protocol of the Ministry of Health, transfer the child to the nearest medical facility.
- Make an appointment to announce test results and re-evaluate.
- Nurturing children
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Albendazole treatment
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
干预措施: Albenza 200Mg Tablet (Drug)
结局指标
主要结局
Procedures Guidelines for diagnosis, treatment, and post-treatment follow-up of Toxocariasis larvae
时间窗: 12 months
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.
次要结局
- 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)
研究者
Thieu Ha Van
Lecturer at Department of Pediatrics (Pham Ngoc Thach University of Medicine), Principal Investigator, Clinical doctor at Children Hospital 2 Ho Chi Minh city, PhD
Pham Ngoc Thach University of Medicine