To assist the Peruvian Ministry of Health in modifying the
malaria treatment policy for their north Pacific coastal region, we conducted an in vivo efficacy trial of
sulfadoxine-pyrimethamine (SP) and SP plus
artesunate (SP-AS) for the treatment for uncomplicated Plasmodium falciparum
infections. A total of 197 patients were randomized to
therapy with either SP (25 mg/kg of the
sulfadoxine component in a single dose on day 0) or a combination of SP plus AS (4 mg/kg on days 0, 1, and 2) and were followed for 28 days for symptoms and recurrence of
parasitemia. No statistically significant differences between the two groups were observed on enrollment with respect to age, sex, history of
malaria, or geometric mean parasite density. A total of 185 subjects completed the 28-day follow-up. Of the 91 subjects treated with SP alone, two had recurrences of
parasitemia on day 7 and one on day 21. Of the 94 subjects treated with SP-AS, one had a recurrence of
parasitemia on day 21.
Fever and asexual parasite density decreased significantly more rapidly and the proportion of patients with gametocytemia on days 3-28 was significantly lower in subjects treated with combination
therapy than in those who received SP alone. No severe
adverse drug reactions were observed; however, self-limited
rash and
pruritus were significantly more common and an exacerbation of
nausea,
vomiting, and
abdominal pain were observed significantly more frequently among patients who had received SP-AS. These results have contributed to a National
Malaria Control Program decision to change to SP-AS combination
therapy as the first-line treatment for uncomplicated P.
falciparum malaria in northern coastal Peru in November 2001, making Peru the first country in the Americas to recommend this combination
therapy.