An observational study in Schistosomiasis in Children, Soil Transmitted Helminth (STH) Infections and Malaria Infection, sponsored by Centre MURAZ/Institut National de Santé Publique. Completed at 1 site in Burkina Faso. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Centre MURAZ/Institut National de Santé Publique · Observational
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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.
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.
2,094 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 300 is close to the median of 300 across 686 observational studies indexed under Infections.
Browse Infections studies →Centre MURAZ/Institut National de Santé Publique is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Schoolchildren from the five selected primary schools in the Banfora community will be included in the study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections
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.
Time frame: January 2025
Intensity of S. mansoni and soil-transmitted helminth (STH) infections
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.
Time frame: January 2025
Intensity of S. haematobium infection
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.
Time frame: January 2025
Risk factors associated with schistosomiasis and soil-transmitted helminth infections
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.
Time frame: January 2025
Cure rate (CR)
The CR is defined as the proportion of egg-positive children at baseline, who become egg-negative after DP treatment in all collected stool or urine samples.
Time frame: 4 weeks and 6 weeks after starting DP treatment
Eggs reduction rate (ERR)
The ERR (defined as the proportional reduction in the mean eggs per gram of faeces (S. mansoni) or per ml of urine (S. haematobium) post-treatment versus pre-treatment)), as assessed by microscopy.
Time frame: 4 weeks and 6 weeks after DP treatment
Drug-related adverse events
The number of participants with drug-related adverse events or serious adverse events
Time frame: First 4 weeks after DP treatment
Prevalence of malaria among schoolchildren
Proportion of children infected with malaria parasites as determined by microscopy and rapid diagnostic test
Time frame: January 2025
Risk factors of malaria among schoolchildren
Potential predictors of malaria including study participants' socio-demographic data and exposure to malaria will be collected using a structured questionnaire. Then predictors significantly associated with the prevalence of malaria will be explored using a multivariable logistic regression.
Time frame: January 2025
Prevalence of anaemia among schoolchildren
Proportion of children with anaemia will determined and anaemia will be defined on the basis of haemoglobin concentration according to (WHO, 2011). Haemoglobin concentration will be measured using a Hemocue photometer from a venous blood sample.
Time frame: January 2025
Risk factors of anaemia among schoolchildren
Key predictors of anaemia, including study participants' socio-demographic data, malaria infection, and helminth infection (i.e, schistosomiasis and STHs infection), will be collected using a structured questionnaire. Then predictors significantly associated with the prevalence of anaemia will be identified using a multivariable logistic regression.
Time frame: January 2025
Ran from Nov 2024 to primary completion in Dec 2024, 1 month.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Centre MURAZ/Institut National de Santé Publique