Abstract

From March to December 2021, this prospective, open-label, single-armobservational clinical trial, conducted in Binh Phuoc, Gia Lai and Phu Yen provinces,evaluated the safety and efficacy of oral Pyronaridine tetraphosphate-Artesunate oncedaily for three consecutive days in adults and children with microscopically confirmedP. falciparum malaria. Patients were treated as in-patients for Days 0–3, with followup visits on Days 7, 14, 21, 28, 35 and 42. The primary outcome was PCR-adjustedadequate clinical and parasitological response (ACPR) at Day 42. The results from 54P. falciparum patients has shown that: The efficacy of Pyronaridine tetraphosphate -Artesunate to P. falciparum has still high, with the rate of ACPR is 100%, the rate ofpositive parasitemia at day 3 is 50%, 54.5% and 54.8% in Binh Phuoc, Phu Yen andGia Lai, respectively. Pyronaridine-Artesunate is safety for the patients. None seriousadverd event are recorded.

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