Innovative Intermittent Preventive Treatment Approaches to Reduce Malaria Burden in School-age Children in Burkina Faso

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be an open label cluster randomized study with two active intervention and one control arm. A cluster will be defined as a selected village. One district implementing seasonal malaria chemoprevention (SMC) will be selected, and six villages will be randomly selected in this district. These six villages will be randomly allocated to each of the three study arms; 1) Arm 1 will receive IPTsc with sulphadoxine-pyrimethamine plus amodiaquine (SPAQ); and 2) Arm 2 will receive dihydroartemisinin-piperaquine (DP) plus Ivermectin (IVM), all given monthly during the transmission season and 3) Control Arm which will have standard malaria control measures including case management and vector control measures as applicable.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Malaria Consortium
• Treatments: Amodiaquine; Artenimol; Fanasil, pyrimethamine drug combination; Ivermectin; Piperaquine; Pyrimethamine; Sulfadoxine

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.