Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed dose combination in the treatment of uncomplicated Plasmodium falciparum malaria.

Ipca Laboratories Limited0 个研究点目标入组 176 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and female patients with age between 18 to 65 years
•2. Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P. falciparum (parasite count between 1000 and 100,000 asexual parasites/µL of blood)
•3. Patients with axillary temperature >/= 37.5 °C and/or history of fever during past 24 hours
•4. Patients with clinical signs and symptoms of malaria
•5. Patients with satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.

•1. Patients with severe malaria as per WHO criteria
•2. Patients with febrile disease other than malaria
•3. Patients with mixed malarial infection
•4. Patients with abnormal heart function including history of QTc prolongation
•5. Patients receiving any concomitant medication which may interact with study drugs
•6. Patients who had taken full course of antimalarials within previous 3 days
•7. Patients with known history of hypersensitivity to any of the study related drugs
•8. Pregnant or lactating women
•9. Women of child bearing potential

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