Thesis
Randomized controlled trial of artesunate plus tetracycline versus standard treatment (quinine plus tetracycline) for uncomplicated plasmodium falciparum malaria in Brazil
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- A triple blind randomized controlled trial was undertaken in a Brazilian Amazon region (Cuiaba-MT), to compare the effectiveness and side effects of oral artesunate (7 days, total dose = 0.75 g) plus tetracycline (7 days, total dose = 10.5 g) (AT) and oral quinine (3 days, total dose = 6 g) plus tetracycline (7 days, total dose = 10.5 g) (QT). Eligible patients had uncomplicated P. falciparum malaria; age $ geq$ 14 years; no previous malaria treatment related to the present attack; and, if women, indication of absence of pregnancy. Clinical exam and blood tests were performed at baseline (day 0) and thereafter at days 2, 4, 7, 14 and 28. Effectiveness was assessed by cure rates (WHO criteria) and parasite clearance at day 2. 176 patients were randomized, 88 to each group. 96.6% of the AT group and 93.2% of the QT group completed the 7-day treatment. 81.8% of the AT group and 78.4% of the QT group completed follow-up visits to day 28. Groups had similar clinical characteristics at baseline. The incidence of side effects was much higher in the QT group (82%) than in the AT group (50%) (p $<$ 0.0001). Cure rates were similar: 80% in the AT and 77% in the QT group (p = 0.68). Parasitemia (by day 2) cleared faster in the AT group than in the QT group (98.5% versus 47.6%, respectively) (p $<$ 0.0001). These results indicate that AT is effective in the treatment of uncomplicated falciparum malaria and may provide a useful alternative to other treatment regimens.
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- 2024-03-14
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