Clinical trial NCT06973200: Burden of Schistosomiasis and Soil-transmitted Helminth Infections in Schoolchildren in Banfora, Burkina Faso
Official title: Epidemiological Profile of Schistosomiasis and Soil-transmitted Helminth Infections Among Schoolchildren in Banfora Municipality, Burkina Faso: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis in Children
Soil Transmitted Helminth (STH) Infections
Malaria Infection
Anaemia
Malnutrition in Children
Keywords: Epidemiology of schistosomiasis and STH infections
Efficacy and safety of dihydroartemisinin-piperaquine
Lead sponsor: Centre MURAZ/Institut National de Santé Publique
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: University of Ghana
First posted: 2025-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Schoolchildren from the five selected primary schools in the Banfora community will be included in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections
timeFrame: January 2025
measure: Intensity of S. mansoni and soil-transmitted helminth (STH) infections
timeFrame: January 2025
measure: Intensity of S. haematobium infection
timeFrame: January 2025
measure: Risk factors associated with schistosomiasis and soil-transmitted helminth infections
timeFrame: January 2025
Secondary outcomes:
measure: Cure rate (CR)
timeFrame: 4 weeks and 6 weeks after starting DP treatment
measure: Eggs reduction rate (ERR)
timeFrame: 4 weeks and 6 weeks after DP treatment
measure: Drug-related adverse events
timeFrame: First 4 weeks after DP treatment
measure: Prevalence of malaria among schoolchildren
timeFrame: January 2025
measure: Risk factors of malaria among schoolchildren
timeFrame: January 2025
measure: Prevalence of anaemia among schoolchildren
timeFrame: January 2025
measure: Risk factors of anaemia among schoolchildren
timeFrame: January 2025
Other outcomes:
Locations:
city: Banfora
country: Burkina Faso
facility: Banfora
state: Comoé
Study officials:
affiliation: Centre MURAZ/Université Nazi BONI
name: Mamoudou Cissé, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: