An Open-label Randomised Trial to Assess the Therapeutic Efficacy and Tolerability of Arterolane-piperaquine Plus Single Low Dose Primaquine Versus Arterolane-piperaquine Plus Mefloquine and Single Low Dose Primaquine Versus Artemether-lumefantrine Plus Single Low Dose Primaquine in the Treatment of Uncomplicated Falciparum Malaria in Children in Kenya

简要总结

主要结局

次要结局

• Parasite clearance half-life(42 days)
• Genome wide association with in vivo/in vitro sensitivity parasite phenotype(Baseline)
• Data on recent travel and current location of living(Baseline)
• Incidence of adverse events concerning markers of hepatic or renal toxicity(42 days)
• Pharmacokinetic profiles and interactions (Cmax) of arterolane and partner drugs(42 days)
• Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm(7 days)
• Incidence of prolongation of the corrected QT interval(42 days)
• Prolongation of the corrected QT interval(Baseline, hour 4, hour 24, hour 28, hour 48 and hour 52)
• Change in haematocrit(Baseline, hour 24, hour 48, hour 72, day 7, day 14, day 21, day 28, day 35 and day 42)
• Proportion of patients that reports completing a full course of observed TACT or ACT(42 days)
• A comparison of transcriptomic patterns between sensitive and resistant parasites(Baseline and 6 hours)
• Proportion of patients with gametocytaemia before, during and after treatment(42 days)
• Levels of RNA transcription coding for male or female gametocytes(Baseline)
• Parasite count to fall 50%(42 days)
• Fever clearance time(42 days)
• Incidence of clinical adverse events and serious adverse events(42 days)
• Prevalence/incidence of other genetic markers of antimalarial drug resistance such as multidrug resistance gene 1 copy number and multidrug resistance gene 1 mutations(Baseline)
• In vitro sensitivity of P. falciparum to artemisinins and partner drugs(Baseline and day recurrent infection)
• Parasite reduction rates(24 and 48 hours)
• Parasite count to fall 90%(42 days)
• Prevalence of Kelch13 mutations of known significance(Baseline)