Therapy of Uncomplicated Falciparum Malaria : A Randomized Trial Comparing Artesunate Plus Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone in Irian Jaya, Indonesia

Tjitra, Emiliana (2001) Therapy of Uncomplicated Falciparum Malaria : A Randomized Trial Comparing Artesunate Plus Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone in Irian Jaya, Indonesia. Project Report. Pusat Penelitian dan Pengembangan Pemberantasan Penyakit.

Abstract

Combining artesunate with existing antimalaria drugs may improve cure rates, delay emergence of resistance, and reduce transmisison. We performend a randomized comparative trial to quantify the effect of adding artesunate to sulfadoxine-pyrimethamine in the treatment of uncomplicated falciparum malaria in Indonesia. Using a modified 1997 World Health Organization protocol for assessment of therapeutic efficacy of antimalaria drugs, 105 patients (stratified by age/ethnic group) were randomized: 53 received artesunate orally 4 mg/kg of body weight, a single daily dose for three days, plus sulfadoxine-pyrimethamine orally (1.25 mg of pyrimethamine/kg of body weight), a single dose on day 0 and 52 patients received sulfadoxine- pyrimethamine alone. Six from the combination group were withdrawn from analysis, as were six of the sulfadoxine-pyrimethamine group. Treatment failure rates on day 14 were 0%in the artesunate plus sulfadoxine-pyrimethamine group and 8.7% in the sulfadoxine-pyrimethamine group (P=0.12). Treatment failure rates on day 28 were 4.4% and 15.2%, respectively (P=0.16). Relative risk of treatment failure at 28 day was 0.3 (95% confidence inteval [CI]=0.1&#8211;1.3). Mean fever clearance time (1.3 versus 1.7 days) and mean parasite clearance time (1.4 versus 2.0 days) were both faster in the artesunate plus sulfadoxine-pyrimethamine group than in the sulfadoxine-pyrimethamine group ( P=0.08 and P < 0.0001, respectively). Only 20 (39.2) of 51 patients treated with artesunate plus sulfadoxine-pyrimethamine were still parasitemic on day 1 compared with 45 (86,5%) of 52 patients treated with sulfadoxine-pyrimethamine alone (P = 0.000001, relative risk [RR]=0.4,95% CI=0.3-0.6). Gametocyte carriage was lower following artesunate plus sulfadoxine-pyrimethamine than following sulfadoxine-pyrimethamine (RR=0.5, 95% CI=0.2-1.0 on day 7 and RR = 0.5, 95% CI=0.2-1.1 on day 14 ). Mild diarrhea, rash and itching resolved without treatment. Combined artesunate plus sulfadoxine- pyrimethamine resulted in more rapid fever and parasites clearance, was well tolerated, reduced risk of treatment failure, and lowered gametocyte carriage.

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