Fixed-dose combination artesunate mefloquine was safe and effective among children aged younger than 5 years with Plasmodium falciparum malaria, according to data presented at the American Society of Tropical Medicine and Hygiene Annual Meeting.
In a phase 4, open-label, multi-center clinical trial, Sodiomon Sirima, PhD, of the Centre National de Recherche et de Formation sur le Paludisme, in Ouagadougou, Burkina Faso, and colleagues randomly assigned 945 children aged from 6 months to 5 years to artesunate mefloquine or artemether lumefantrine for 3 days. Children aged 6 to 11 months who received artesunate mefloquine took a 25-mg/55-mg tablet once daily; children aged 12 to 59 months took two tablets. Children who received artemether lumefantrine took either one 20-mg/120-mg tablet twice daily or two tablets twice daily. Study participants were followed for 63 days. The study was conducted in Burkina Faso, Kenya and Tanzania.
On day 28, PCR indicated artesunate mefloquine had an efficacy of 97.5% vs. 94.6% for artemether lumefantrine. On day 42, artesunate mefloquine had an efficacy of 93.6% compared with 92.1% for artemether lumefantrine. On day 63, artesunate mefloquine had an efficacy of 90.9% vs. 89.7% for artemether lumefantrine.
There were few cases of vomiting that led to treatment discontinuation in both groups.
“The artesunate mefloquine fixed-dose combination has proven its importance among tools recommended by WHO and can now be available to African children suffering from uncomplicated falciparum malaria,” Bernard Pécoul, MD, MPH, DSc, executive director of the Drugs for Neglected Diseases initiative, which funded the study, said in a press release. “Considering that a child dies every 30 seconds from malaria, we hope that governments in affected African countries will now take up this additional treatment option to ensure their populations have access to several artemisinin-based combination therapies.”
For more information:
Sirima S. #1483. Presented at: American Society of Tropical Medicine and Hygiene Annual Meeting; Nov. 2-6, 2014; New Orleans.
Disclosure: Infectious Diseases in Children was unable to confirm financial disclosures at the time of publication.