Per-protocol population analysis
malaria, parasitaemia, vomiting
MALARIA, RECURRENCE, REINFECTION
There was no case of early treatment failure during the study. Response to treatment was prompt in all study participants except in an enrollee among AL treated children who had recurrent vomiting and had to be withdrawn on day 0. By day 1, 11.6% (10/86) and 12.9% (n = 11/85) of patients treated with AL and PA respectively were free of patent parasitaemia while corresponding values for day 2 were 70.9% (n = 61/86) and 72.9% (n = 62/85) for AL and PA, respectively. Two (2.3%) of the study participants who received AL had patent parasitaemia at day 3, but they both recorded adequate clinical and parasitological responses at day 28. None of those treated with PA had patent parasitaemia on Day 3. All participants were free of patent parasitaemia by day 7. However, two children among those who received AL failed treatment at day 14, one each recorded LCF and LPF.In contrast to those treated with AL, treatment failure was first seen among children who received PA on day 21. The ACPR in the per-protocol population at day 21 was significantly higher for PA than for AL treated children (98.8% vs. 88.0%, respectively, The cumulative incidence of ACPR over 28 days among PA treated children without PCR-correction and PCR-corrected were 92.7% (95% CI (84.6–96.7) and 97.4% (95% CI 90.8–99.4), respectively. For AL treated children, the cumulative incidence of ACPR over 28 days without PCR-correction and PCR-corrected were 71.1% (95% CI 60.3–79.8) and 88.1% (95% CI 80.9–94.9). In calculating the PCR corrected cure rates, the cases of reinfection were censored and as such were not included in the numerator or denominator.The efficacy outcomes observed by age in the per-protocol population are as shown in Table Treatment outcome among children (PP) from southwest Nigeria with acute uncomplicated malaria treated with artemether–lumefantrine or pyronaridine–artesunate in different age groupsAll the 30 children with parasite recurrence among per-protocol (PP) population—[6/82 (7.3%) for PA vs. 24/83 (28.9%) for AL; 