Artemether-lumefantrine for the treatment of Plasmodium malariae, Plasmodium ovale, and mixed Plasmodium malaria: A prospective clinical trial assessing species-specific efficacy in Gabon [PublishAheadOfPrint]

Objectives

Treatment recommendations for Plasmodium malariae and Plasmodium ovale malaria are largely based on anecdotal evidence. The aim of this study was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated P.malariae or P.ovale mono-infections, or mixed Plasmodium infections.

Patients and methods

This prospective study was conducted in Gabon. Patients with microscopically confirmed P.malariae, P.ovale, or mixed species malaria with at least one of these two Plasmodium species were treated with an oral, fixed dose combination of artemether-lumefantrine for three consecutive days. The primary endpoints were per protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period.

Results

72 participants (42 male, 30 female) were enrolled, 62.5% of them were PCR corrected mixed Plasmodium infections. Per protocol, PCR corrected ACPR was 96.6% (95%CI 91.9 - 100) on day 28 and 94.2% (95% CI 87.7–100) on day 42. Considering Plasmodium species independently from their co-infecting species, day 42 ACPR was 95.5% (95% CI 89.0–100) for P.falciparum, 100% (exact CI 84.6–100) for P.malariae, 100% (exact CI 76.8–100) for P.ovale curtisi and 90.9% (95% CI 70.7–100) for P.ovale wallikeri. Study drug related adverse events were generally mild or moderate.

Conclusion

This largest clinical trial assessing the efficacy of an antimalarial against non-falciparum malaria demonstrated satisfying antimalarial activity of artemether-lumefantrine against P.ovale wallikeri, P.ovale curtisi, P.malariae, and mixed Plasmodium infections with per protocol efficacies of 90%–100% without evident tolerability or safety concerns.

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