Discussion
fever, malaria, vomiting, infection, malaria infection, headache, rigors, chills, anorexia
MALARIA, ADVERSE EVENTS, INFECTION, ROTH, FALCIPARUM MALARIA, ANOREXIA
During this study, the comparative efficacy and safety of PA and AL in the treatment of acute uncomplicated falciparum malaria among Nigerian children aged 3–144 months with parasite densities that ranged from 1035/µL to 1,652,505/µL were evaluated. Even though children with parasite density above 200,000/µL, were enrolled into the study, no clinical case of severe malaria was enrolled as none of the children enrolled into the study had their malaria infection complicated by serious organ failures or abnormalities in the patient's blood or metabolism. Children who live in malaria endemic regions, like Nigeria, frequently present to malaria clinic with parasite densities > 200,000/µL and are successfully treated with oral anti-malarial medications as outpatients [The trial participants tolerated the two artemisinin-based combinations satisfactorily. There was no record of early treatment failure in either arm of the study, and only one participant who received AL was withdrawn as a result of recurrent vomiting. PA was found to be significantly more efficacious than AL among both the intent-to-treat (89.4% vs. 67.8%, A highly significant efficacy finding in this study is that PA had a statistically significantly higher ACPR than AL in both the intent-to-treat (89.4% vs. 67.8%; The day-28 PCR-corrected cure rate among the children with uncomplicated falciparum malaria treated with PA granules or tablets was 97.4% (76/78) in the per-protocol population, while the PCR-corrected cure rate among AL treated enrollees was 88.1% (59/67) after censoring cases with reinfections. The Kaplan–Meier survival estimates also showed that the cumulative incidence of ACPR over the 28 days of follow-up in the Pyronaridine-Artesunate group was significantly higher than that in the Artemether–Lumefantrine group without PCR correction (It is particularly noteworthy that PA demonstrated a statistically significant higher PCR uncorrected efficacy among under 5-year-olds during this study [96.0% vs. 63.6% for PA and AL, respectively, as shown in Table There was no difference in parasite clearance time between PA and AL treated groups, and the findings during this study are consistent with Roth and colleagues' findings among Kenyan children [In this study, both AL and PA had good safety profiles. The commonly observed adverse events were fever, chills, rigors, anorexia, and headache. These symptoms are like those seen in malaria patients and resolve as the infection is cleared. These findings are consistent with those reported by earlier researchers [Another notable finding from the present study is that from days 0 to 21, gametocyte carriage was consistently higher among PA-treated children compared to AL-treated children, but the observed differences were not statistically significant (Additional file This study's findings should be viewed with a few caveats in mind. The current study included only eight children under the age of 12 months, of which only five were randomly assigned to the pyronaridine–artesunate group. Even though the ACPR for the PA group was 100 percent on day 28, the number of enrollees is insufficient to draw any conclusions about efficacy and safety in that age group. As a result, more information on this patient population is needed for pyronaridine–artesunate.