Schistosomiasis in ChildrenNTDs_SACNCT06973200
Burden of Schistosomiasis and Soil-transmitted Helminth Infections in Schoolchildren in Banfora, Burkina Faso
An observational study of Schistosomiasis in Children and Soil Transmitted Helminth (STH) Infections, run by Centre MURAZ/Institut National de Santé Publique at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis in Children, Soil Transmitted Helminth (STH) Infections, Malaria Infection
- What is being tested?
- Dihydroartemisin-piperaquine
- How many people
- 300 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 11 Nov 2024to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Schoolchildren from the five selected primary schools in the Banfora community will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Profile of Schistosomiasis and Soil-transmitted Helminth Infections Among Schoolchildren in Banfora Municipality, Burkina Faso: a Pilot Study
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.
Read the 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.
- Conditions
- Schistosomiasis in Children, Soil Transmitted Helminth (STH) Infections, Malaria Infection, Anaemia, Malnutrition in Children
- Being tested
- Dihydroartemisin-piperaquine
- Keywords
- Epidemiology of schistosomiasis and STH infections, Efficacy and safety of dihydroartemisinin-piperaquine
- Medical subject headings
- Infections, Anemia, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisin-piperaquineCombination product
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2025
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start11 Nov 2024
- Primary completion21 Dec 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosomiasis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre MURAZ/Institut National de Santé Publique
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Ghana
- Responsible party
- Sponsor
- Investigators
- Mamoudou Cissé, MD, MSc, PhD, Principal investigator, Centre MURAZ/Université Nazi BONI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973200
- Sponsor's protocol ID
- INSP_CM_08_2024
- Other IDs
- ACE02-WACCBIP
- Acronym
- NTDs_SAC
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Profile of Schistosomiasis and Soil-transmitted Helminth Infections Among Schoolchildren in Banfora Municipality, Burkina Faso: a Pilot Study
- ClinicalTrials.gov ID
- NCT06973200
- Acronym / sponsor ID
- NTDs_SAC / INSP_CM_08_2024
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre MURAZ/Institut National de Santé PubliqueOther government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Ghana
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Schoolchildren from the five selected primary schools in the Banfora community will be included in the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroartemisin-piperaquineAll 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. | Combination product | – |
Primary outcome
Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Cure rate (CR)
Time frame: 4 weeks and 6 weeks after starting DP treatment
Eggs reduction rate (ERR)
Time frame: 4 weeks and 6 weeks after DP treatment
Drug-related adverse events
Time frame: First 4 weeks after DP treatment
Prevalence of malaria among schoolchildren
Time frame: January 2025
Risk factors of malaria among schoolchildren
Time frame: January 2025
Prevalence of anaemia among schoolchildren
Time frame: January 2025
Risk factors of anaemia among schoolchildren
Time frame: January 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Schistosomiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamoudou Cissé, MD, MSc, PhD principal investigator
Centre MURAZ/Université Nazi BONI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis in Children and Soil Transmitted Helminth (STH) Infections, run by Centre MURAZ/Institut National de Santé Publique at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of schistosomiasis and soil-transmitted helminth (STH) infections (time frame: January 2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.