Pyronaridine is a new
antimalarial agent developed in China. In this randomized, unblinded study, the safety, tolerance, and clinical efficacy of
pyronaridine (n = 44) were evaluated and compared with those of
chloroquine (n = 44), the standard first-line
antimalarial drug in most of Africa, in 88 Cameroonian children with acute uncomplicated
falciparum malaria. The target sample size was determined to detect a 35% difference 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
pyronaridine 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 children treated with
chloroquine. In vitro assays indicated that 23 of 40 clinical isolates obtained from patients treated with
pyronaridine were resistant in vitro to
chloroquine. Side effects associated with
pyronaridine intake were minor and transient.
Pyronaridine is safe and well tolerated by symptomatic Cameroonian children, and it is highly efficacious in Africa, where
chloroquine resistance is well established.