Burden of Schistosomiasis and Soil-transmitted Helminth Infections in Schoolchildren in Banfora, Burkina Faso

NCT06973200 | Completed DMC

• 2 other identifiers: INSP_CM_08_2024ACE02-WACCBIP
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  January 2025

Secondary Outcomes (7)

• 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

Interventions

Dihydroartemisin-piperaquine COMBINATION_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.

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Schoolchildren from the five selected primary schools in the Banfora community will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre MURAZ/Institut National de Santé Publique: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• University of Ghana: collaborator

Study Sites (1)

Banfora

Banfora, Comoé, Burkina Faso

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and urines samples

MeSH Terms

Conditions

Infections; Anemia; Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mamoudou Cissé, MD, MSc, PhD

  Centre MURAZ/Université Nazi BONI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: May 15, 2025
• Study Start: November 11, 2024
• Primary Completion: December 21, 2024
• Study Completion: February 25, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-01

Locations

BU (1)