Many countries in Africa are now confronted with the dilemma of shifting dr
ug policies for uncomplicated falciparum malaria from chloroquine, which ha
s become largely ineffective, to a new first-line drug and amodiaquine is o
ne of the possible options. A multicentre, open-label randomized controlled
trial of amodiaquine 30 mg/kg vs chloroquine 25 mg/kg over 3 days was perf
ormed in Senegal, Cameroon, Gabon, and Burkina Faso between 1996 and 1998 a
nd patients were followed-up for 14 days. Sensitivity of isolates in vitro
and whole blood levels of chloroquine and amodiaquine were also measured. T
he primary efficacy parameter was parasitological clearance on day 14 (para
sitological success). The secondary efficacy parameter was absence of signs
/symptoms of malaria on day 14 (clinical success). Among the 364 patients r
andomized and receiving the assigned treatment (chloroquine n = 185, amodia
quine n = 179), 137 and 139, respectively, reached the primary endpoint. Am
odiaquine proved significantly more effective than chloroquine. The summary
odds ratio (95% CI) was 7 . 79 (4 . 54-13 . 35) for parasitological succes
s, and 6 . 3 (3 . 4 -11 . 68) for clinical success. Sensitivity in vitro an
d chloroquine blood levels were good predictors of chloroquine failure. Amo
diaquine remains effective for treating uncomplicated falciparum malaria in
areas of West and Central Africa where chloroquine resistance is prevalent
. However, measures should be taken to protect the lifespan of amodiaquine
where the drug is introduced for use.