Clinical Safety Profiles of Artesunate and Amodiaquine in Combination with Sulphadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children

Clinical symptoms serve strong indicators for clinical recoveries and the safety of antimalarials. The present study evaluated the safety of Artesunate + Sulphadoxine - Pyrimethamine (AT+SP) and Amodiaquine + Sulphadoxine Pyrimethamine (AQ+SP) combination therapies in the treatment and recovery trends of eight different clinical symptoms. The study was carried out in malaria holo-endemic settlements in northern Nigeria between July - December 2013 on 313 children with uncomplicated Plasmodium falciparum malaria. Preliminary investigations show that malaria was accompanied by high clinical symptoms (greater than 60 %) in both drug treatment groups at enrolment. There were no drug contraindication on abdominal pain, diarrhea, insomnia and prurities as inferred from the progressive symptom recoveries throughout follow-up period. However, signs of drug adverse effects were expressed for dizziness, headache, and nausea and vomiting, inferred from symptom upsurge within 3 days. In general, the regression trend lines indicate 4 - 5 days mean symptom resolution period, except headache which extended to 5 - 6 days. In conclusion, both AT + SP and AQ + SP could be adjudged safe based on rapid symptom resolution and the short relapse of triggered contraindications in few patients.