New treatments to prevent malaria in school-age children in Burkina Faso
Clinical Trial to Evaluate Efficacy and Safety of Sulfadoxine/Pyrimethamine-Amodiaquine and Dihydroartemsinin-Piperaquine Plus Ivermectin Administered Monthly as Intermittent Preventive Treatment in School-aged Children in Burkina Faso
This study is testing two new ways to prevent malaria in school-age children in Burkina Faso to see if they work better than the usual methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 13000 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | Malaria Consortium Academic / other |
| Locations | 1 site (Ouagadougou) |
| Trial ID | NCT05946642 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of two innovative intermittent preventive treatments for malaria in school-age children in Burkina Faso. It involves an open-label cluster randomized design with three arms: one receiving sulphadoxine-pyrimethamine plus amodiaquine, another receiving dihydroartemisinin-piperaquine plus Ivermectin, and a control group receiving standard malaria control measures. The study aims to assess the impact on malaria burden, implementation feasibility, and cost-effectiveness of these treatments during the malaria transmission season.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 15 years residing in the selected villages of the study area.
Not a fit: Patients with serious illnesses, allergies to study medications, or those currently participating in other research projects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of malaria among school-age children in the targeted regions.
How similar studies have performed: Previous studies have shown promise in using similar preventive treatment approaches for malaria, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Resident in the study area and willing to remain there for the study duration * Age \> or = 5 and \< 15 years * Willing to provide biological samples as requested during the study period * Provision of informed consent by parents/guardians * Provision of assent from children aged 12 to 15 years. Exclusion Criteria: * Any serious illness or medical situation that could interfere with follow-up * Inability to take study medication * History of known allergy or contraindication to study drugs * History of cardiac disorders or prolonged QT syndrome * Current use of drugs known to prolong QT interval * Participating in another research project.
Where this trial is running
Ouagadougou
- Malaria Consortium — Ouagadougou, Burkina Faso (Recruiting)
Study contacts
- Principal investigator: Jane Achan, PhD — Malaria Consortium
- Study coordinator: Jane Achan, PhD
- Email: j.achan@malariaconsortium.org
- Phone: +256770410183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.