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

M. Kokori, M. M. Suleiman, L. S. Kela

Abstract: 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 (> 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.

Keywords: malaria, clinical, safety, recoveries, antimalarials,