Recurrence of and Following Treatment of Uncomplicated Malaria in North Sumatera With Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine.

Background: We assessed the efficacy of artemisinin-based combination therapies for treatment of uncomplicated malaria, with or without co-infecting spp., in Sumatera, Indonesia.

Methods: Febrile patients aged >6 months with uncomplicated were randomized to receive dihydroartemisinin-piperaquine or artemether-lumefantrine, plus single-dose primaquine, and were followed for 42 days. Mixed infections were included; infections received 14 days of primaquine. We retrospectively restricted the analysis to cases with polymerase chain reaction (PCR)-confirmed parasitemia. Recurrent parasitemia in follow-up was identified by species-specific nested PCR.

Results: Of the 3731 participants screened, 302 were enrolled and randomized. In the dihydroartemisinin-piperaquine arm, infections were confirmed by PCR in 59 participants, with mixed infections in 23 (39.0%). In the artemether-lumefantrine arm, infections were confirmed by PCR in 55 participants, with mixed infections in 16 (29.0%). Both regimens were well tolerated, and symptoms improved rapidly in all treated participants. In the dihydroartemisinin-piperaquine arm, 1 recurrence (on day 7) and 6 recurrences (1 had a mixed infection with ) were identified during days 3-42 of follow-up. In the artemether-lumefantrine arm, 1 recurrence occurred on day 35. Submicroscopic persistence occurred during follow-up in 21 (37%) of 57 receiving dihydroartemisinin-piperaquine and 20 (39%) of 51 receiving artemether-lumefantrine.

Conclusions: In Sumatera, both regimens effectively cleared initial parasitemia, but and persisted in some individuals. Molecular species detection should be deployed in antimalarial efficacy trials in Indonesia.

Trial Registration: NCT02325180.