Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy
Status:
Active, not recruiting
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
This is a randomised, open label trial, comparing standard dose of
dihydroartemisinin-piperaquine (DP) with standard fixed artesunate-mefloquine regimen (MAS3)
and with a longer regimen of artemether-lumefantrine (ALN+) in the treatment of uncomplicated
malaria in pregnant women. The sample size is 335 women in each arm which would be 1005 women
in total. Pregnant patients in 2nd and 3rd trimester with acute uncomplicated malaria who
meet eligibility criteria will be asked to participate in the study. The primary objective is
to determine if the efficacy of DP and MAS3 are superior to ALN+ in the treatment of
uncomplicated malaria in pregnancy. The study will also incorporate a dense pharmacokinetic
study of mefloquine and artesunate (15 women in the MAS3 arm) and a population
pharmacokinetic study for mefloquine, piperaquine and lumefantrine.