RESUMEN
The efficacy and safety of a fixed-dose combination of atovaquone and proguanil hydrochloride (Malarone TM) were compared with chloroquine or pyrimethamine/sulfadoxine in patients with acute falciparum malaria in northern Peru. Patients were initially randomized to receive, 1,000 mg atovaquone and 400 mg mg proguanil hydrochloride daily for 3 days (n=15) or 1,500 mg chloroquine (base) over a 3 day period (n=14) (phase 1). The cure rate with chloroquine was lower than expected and patients were subsequently randomized to receive a single dose of 75 mg pyrimethamine and 1,500 mg sulfadoxine (n=9) or atovaquone/proguanil as before (n=5) (phase 2). In phase 1, atovaquone/proguanil was significantly more effective than chloriquine (cure rate 100 percent [14/14] versus 8 percent [1/13], P<0.0001). In phase 2, atovaquone/proguanil and pyrimethamine/sulfadoxine were both highly effective (cure rates 100 percent [5/5] and 100 percent [7/7]). There were no significant differences between treatment groups in parasite or fever clearance times. Adverse events were typical of malarium symptoms and did not differ significantly between groups. Overall efficacy of atovaquone/proguanil was 100 percent for treatment of acute falciparum malaria in a region with a high prevalence of chloroquine resistance.