U: Dihydroartemisinin-piperaquine and artemetherlumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial. PLoS One 2009

Background: Artemisinin combination therapies (ACTs) are currently the preferred option for treating uncomplicated malaria. Dihydroartemisinin-piperaquine (DHA-PQP) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children. Methodology/Principal Findings: The non-inferiority of DHA-PQP versus artemether-lumefantrine (AL) in children 6–59 months old with uncomplicated P. falciparum malaria was tested in five African countries (Burkina Faso, Kenya, Mozambique, Uganda and Zambia). Patients were randomised (2:1) to receive either DHA-PQP or AL. Non-inferiority was assessed using a margin of 25 % for the lower limit of the one-sided 97.5 % confidence interval on the treatment difference (DHA-PQP vs. AL) of the day 28 polymerase chain reaction (PCR) corrected cure rate. Efficacy analysis was performed in several populations, and two of them are presented here: intention-to-treat (ITT) and enlarged per-protocol (ePP). 1553 children were randomised, 1039 receiving DHA-PQP and 514 AL. The PCR-corrected day 28 cure rate was 90.4 % (ITT) and 94.7 % (ePP) in the DHA-PQP group, and 90.0 % (ITT) and 95.3 % (ePP) in the AL group. The lower limits of the one-side