A prospective, open-label, multi-center, post marketing study to evaluate safety and efficacy of fixed dose combination (FDC) tablets of arterolane maleate and piperaquine phosphate (PQP) in Indian patients with acute uncomplicated falciparum malaria.

Ranbaxy Laboratories Ltd0 个研究点目标入组 400 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive Rapid Diagnostic Test (RDT) for P. Falciparum.
•Presence of fever (>= 99 Â°F) or a documented history of fever in the past 24 hours.

•Patients not willing to provide written informed consent for participation in clinical study.
•Patients with severe malaria namely, impaired consciousness, convulsions, jaundice, bleeding, pulmonary edema or requires hospitalization
•Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae).
•Age 12 or 65 years
•Known allergy to artesunate, artemether, artemisinin derived products, lumefanterine, piperaquine or any other related drug.
•Patients with significant renal or hepatic impairment
•Pregnant and Lactating women

发起方

Ranbaxy Laboratories Ltd