Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand

Artemether-lumefantrine will be administered according to body weight, twice a day over 3 days, as per WHO recommended dose (WHO guidelines). Tablets containing 20mg base of artemether and 120 mg base of lumefantrine will be administered orally. The number of tablets administered is based on the weight of the patient, twice a day, over three days – 1 tablet for patients of 5-14kg, 2 for patients of 15-24kg, 3 for patients of 25-34kg, 4 over 34kg. All antimalarial drug(s) must be stored in a cool dry environment. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The therapeutic efficacy study will be carried out in the field clinic and 3-day treatment will be given at field clinic or their home by visiting each day for 3 days as in most malarious places public transport system is not available. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy