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临床试验/NCT06973200
NCT06973200已完成不适用

Epidemiological Profile of Schistosomiasis and Soil-transmitted Helminth Infections Among Schoolchildren in Banfora Municipality, Burkina Faso: a Pilot Study

Centre MURAZ/Institut National de Santé Publique1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections

研究概览

简要总结

A cross-sectional study will be conducted among 300 schoolchildren in the Banfora region, including 120 in urban and 180 in rural areas, to assess the prevalence of schistosomiasis and soil-transmitted helminth infections. All children with S. mansoni and/or S. haematobium infections at enrolment will then be treated with dihydroartemisinin-piperaquine (DP) and followed up on days 1, 2, 3, 4, 28, and 42 to assess the efficacy and safety of DP. At the end of the study, all children (infected and uninfected) will receive praziquantel and albendazole according to national recommendations.

详细描述

At enrolment, pre-tested structured questionnaire will be administered to each enrolled child and his/her parent or legal guardian to collect socio-demographic data (age, sex, class), exposure factors to schistosomiasis and soil-transmitted helminth infections (eating and drinking habits, wearing of shoes, use of latrines and contact with water) and disease history. In addition, the child's clinical data (body temperature, weight and height) will be collected. Axillary temperature is measured with an electronic thermometer. Weight and height are measured using a mechanical scale and a height gauge with an accuracy of 0.1 cm and 0.1 kg, respectively, according to standard procedures.

A venous blood sample (4 mL) will then be taken to test for malaria and to measure haemoglobin concentration. The remaining blood sample will be stored for future study. Children with confirmed malaria infection or anaemia will be treated with dihydroartemisinin-piperaquine (DP) or iron folic acid according to national recommendations. In addition, each participant will receive two pre-labeled (identification code and date) sterile plastic containers to collect stool and urine samples. The stool samples will be used to diagnose S. mansoni infection and soil-transmitted helminth infections, while the urine samples will be used to detect circulating S. mansoni antigens and S. haematobium eggs. The urine samples will be collected on the day of enrolment, while the stool containers will be collected the following morning (each child will be instructed to place part of their stool sample in the container). Part of the biological samples will be processed in the laboratory of the Banfora Urban Medical Centre. The remaining biological samples will then be stored in the same laboratory before being transported in refrigerated containers to the Parasitology-Mycology Laboratory of the Centre MURAZ, where they will be archived for ten years.

Upon enrolment, only children infected with S. mansoni and/or S. haematobium will be treated with DP and followed up on days 1, 2, 3, 4, 28, and 42 to assess the efficacy and safety of DP. Project nurses will administer all doses of DP, and participants will be monitored for 30 minutes. Any participant who vomits during the first 30 minutes will be given a replacement dose. Participants with repeated vomiting will be excluded from the study and managed according to national guidelines. However, at the end of the study, all schoolchildren will be treated with PZQ (40 mg/kg) and albendazole (400 mg) according to national guidelines.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 5 and 15 years;
  • Resident in Banfora town for at least 6 months before the start of the study;
  • Assent of the child (over 12 years of age);
  • Informed consent from the child's parent or legal guardian.

排除标准

  • Use of praziquantel and albendazole in the past 6 months;
  • Use of Artemisinin-based combination therapies (ACTs) in the 3 weeks before study start-up;
  • Known allergy to DP;
  • Current episode of diarrhoea;
  • Inability to provide stool and urine samples;
  • Child absent on the day of the survey.

结局指标

主要结局

Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections

时间窗: January 2025

Porportion of children infected by schistosomes and soil-transmitted helminths. S. mansoni and STHs will be screened using the Kato Katz method while S. haematobium will be detected using the urine filtration method.

Intensity of S. mansoni and soil-transmitted helminth (STH) infections

时间窗: January 2025

The intensity of S. mansoni and STH infections will be determined using the Kato-Katz method and expressed as the number of eggs per gram of feces.

Intensity of S. haematobium infection

时间窗: January 2025

The intensity of S. haematobium infection will be determined using urine filtration method and expressed as the number of eggs per 10 mL of urine.

Risk factors associated with schistosomiasis and soil-transmitted helminth infections

时间窗: January 2025

Potential predictors of schistosomiasis and soil-transmitted helminth infections, such as study participants' socio-demographic data, WASH conditions, and exposure to water bodies, will be collected using a structured questionnaire. Multivariable logistic regression will be used to explore predictors significantly associated with the prevalence of schistosomiasis and soil-transmitted helminth infections.

次要结局

  • Cure rate (CR)(4 weeks and 6 weeks after starting DP treatment)
  • Eggs reduction rate (ERR)(4 weeks and 6 weeks after DP treatment)
  • Drug-related adverse events(First 4 weeks after DP treatment)
  • Prevalence of malaria among schoolchildren(January 2025)
  • Risk factors of malaria among schoolchildren(January 2025)
  • Prevalence of anaemia among schoolchildren(January 2025)
  • Risk factors of anaemia among schoolchildren(January 2025)

研究者

发起方
Centre MURAZ/Institut National de Santé Publique
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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