None listed
Conditions
Brief summary
To monitor the efficacy and safety of artemether-lumefantrine and artesunate amodiaquine in the treatment of uncomplicated falciparum malaria in two sentinel sites in Togo
Interventions
Artemether-lumefantrine tablets, each containing 20 mg of artemether and 120 mg of lumefantrine, will be administered twice daily for 3 consecutive days. Children with body weight of 5-14 kg will receive one tablet morning and evening and chidren from 15 kg up to 24 kg will received 2 tablets morning and evening. Patients treated with artesunate plus amodiaquine will be administered oral tablets of artesunate at a dose of 4 mg/kg/day up to a maximum of 250 mg per day and oral tablets of amodiaquine at a dose of 10/kg/day up to a maximum of 600 mg per day for three consecutive days. Patients will be observed for 28 days follwoing initiation of treatment. Artemether-lumefantrine and artesunate plus amodiaquine treatments correspond to the first and second line antimalarial treament policy (standard of care) in Togo, respectivlely.
Sponsors
Eligibility
Inclusion criteria
age between 6 and 59 months microscopically confirmed monoinfection with P falciparum parasitemia (asexual forms) between 2000 and 200 000 per microliter fever (body temperature of 37.5 C or greater) able to swallow medication able to comply with protocol assessment schedule
Exclusion criteria
clinical signs and symptoms of severe malaria infection with another Plasmodium species or co-infection severe malnutrition fever due to other diseases