Randomized double-blinded controlled clinical trial to assess the efficacy of Dihydroartemisinin-Piperaquine compared to Sulfadoxine-Pyrimethamine associated to Amodiaquine in SMC in school aged children from 6-15 years in Mali

Seasonal Malaria Chemoprophylaxis with Sulfadoxine-Pyrimethamine associated to Amodiaquine (SP-AQ) is a malaria control strategy that targets children aged 3-59 months in areas where 60% or more of malaria transmission and disease burden occur in the rainy season over a period of about 4 months. School-aged children are not currently targeted by SMC in all countries and constitute a neglected population afflicted by seasonal malaria in countries where SMC is implemented. Modelling studies indicates that scale up of malaria interventions with high impact on disease burden may lead to an age shift in malaria burden. Evidence from field trials indicates that extending the age range for SMC may lead to reduced transmission of malaria and could contribute to programs to eliminate malaria transmission. SP-AQ is the currently recommended regimen for SMC and SP is also used in intermittent preventive treatment (IPT) in pregnant women. Pyrimethamine is known to rapidly select DHFR gene mutations associated with drug resistance to SP, therefore, SP is threatened by the rise and spread of drug resistant parasites. Hence, there is a need to have alternative drug regimens for SMC. Dihydroartemisinin-Piperaquine (DHA-PQ) is a long acting artemisinin-based combination therapy that is recommended by WHO for first line cure of uncomplicated malaria. 

• Allocation: Randomised
• Intervention Model: Factorial
• Intervention Model Description: Participants randomly allocated to either no, one, some or all interventions simultaneously.
• Masking: Double blinded

Trial number: PACTR202007754558749

Project details

Drug-based Strategies
Vulnerable Populations

Sep 2020 — Sep 2021

Mali

Seasonal Malaria Chemoprevention (SMC)