Purpose: The aim of this study was to investigate the efficacy of artemether-lumefantrine in treating uncomplicated Plasmodium falciparum malaria in four sentinel areas in Sudan with different malaria transmission (Damazin, Sinnar, and Kosti in the north, and Juba in the south).
Methods: World Health Organization protocol for assessing antimalarial drug efficacy in treating uncomplicated P. falciparum malaria was employed. A total of 2,139 patients were screened, and 771 had P. falciparum monoinfection. Only 291 met the enrollment criteria and gave written consent to be recruited in the study. Patients were treated with artemether-lumefantrine tablets in a six-dose regimen calculated according to body weight. Tablets were given at 0, 8, 24, 36, 48, and 60 h. Patients were followed up for 28 days.
Results: A total of 291 patients were recruited to the study, of whom ten [3.4; 95% confidence interval (CI):1.8-6.4%] patients showed early treatment failure (ETF) or late clinical failure (LCF) and were excluded from further follow-up. Of the remaining 281 patients, 276 (98.2%; 95% CI: 95.7-99.3%) completed the 28-day follow-up. Of these, 274 (99.3%; 95% CI: 97.1-99.9%) had adequate clinical and parasitological response (ACPR), and two (0.7%; 95% CI: 0.13-2.9%) showed late parasitological failure (LPF) at days 21 and 28. The overall mean +/- standard deviation (SD) of parasitemia and fever clearance times were 36.4 (23.7) h and 34.6 (19.2) h, respectively. Mild and reversible adverse effects were reported by 11 patients (3.8%; CI: 2.0- 7.0%) and were relieved without the need for termination of drug therapy or supportive treatment.
Conclusions: Our findings showed that artemether-lumefantrine was an effective and safe drug for treating uncomplicated P. falciparum malaria in northern and southern Sudan.