EFFICACY OF ORAL PYRONARIDINE FOR THE TREATMENT OF ACUTE UNCOMPLICATED FALCIPARUM-MALARIA IN AFRICAN CHILDREN

Pyronaridine is a new antimalarial agent developed in China. In this r andomized, unblinded study, the safety, tolerance, and clinical effica cy of pyronaridine (n = 44) were evaluated and compared with those of chloroquine (n = 44), the standard first-line antimalarial drug in mos t of Africa, in 88 Cameroonian children with acute uncomplicated falci parum malaria. The target sample size was determined to detect a 35% d ifference in in vivo resistance between the two treatment groups, with 95% power. Clinical and parasitological responses were monitored for 14 days on an outpatient basis. Seven children (3 treated with pyronar idine and 4 treated with chloroquine) were lost to follow-up and were excluded from the analysis. All 41 patients treated with pyronaridine were cured. Treatment failure was observed in 16 (40%) of the 40 child ren treated with chloroquine. In vitro assays indicated that 23 of 40 clinical isolates obtained from patients treated with pyronaridine wer e resistant in vitro to chloroquine. Side effects associated with pyro naridine intake were minor and transient. Pyronaridine is safe and wel l tolerated by symptomatic Cameroonian children, and it is highly effi cacious in Africa, where chloroquine resistance is well established.