School-aged children based seasonal malaria chemoprevention using artesunate-amodiaquine in Mali
To test the efficacy and safety of Seasonal Malaria Chemoprevention (SMC) using artesunate - amodiaquine (ASAQ) in school-aged children from a peri urban setting of Mali.
SMC is an efficient control strategy recommended by WHO that targets children under five year old living in areas of seasonal malaria transmission. SMC uses the combination amodiaquine (AQ) – sulfadoxine-pyrimethamine (SP). However SP selects rapidly drug resistant parasites. This pilot study assessed an alternative approach to SMC in older children in Mali.
Overall, 20 cases of uncomplicated clinical malaria were encountered in the Control arm and 3 cases in the ASAQ arm, showing a protective efficacy of 85% 95% CI [80.1–89.9] against clinical malaria. Protective efficacy against malaria infection was 69.6% 95% CI [58.6–21.4]. No effect on anemia was observed. ASAQ was well tolerated. Most common solicited adverse events were abdominal pain and headaches of mild intensity in respectively 64% and 44% of children that swallowed ASAQ.
This was an open-label, randomized controlled clinical trial designed to assess the efficacy and safety of SMC using ASAQ in school-aged children.
Two hundred pupils aged 6–15 years old were enrolled and randomized into two arms of 100 each, to receive either ASAQ monthly or no intervention. Both arms were followed and clinical malaria were diagnosed and treated with arthemeter-lumefanthrine as recommended by Mali National Malaria Control Program. ASAQ was administered 3 days under study team direct observation and during 4 consecutive months starting in October 2013. Follow up was continued until April 2014.