Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Malaria in Pregnancy
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in
sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can
significantly reduce malaria-related morbidity and mortality in the mother and baby. However,
therapeutic choices are limited by concerns about possible toxicity to the fetus and because
of these concerns pregnant women are normally excluded from clinical trials. This, combined
with the lack of adverse events reporting system, results in a scarcity of data on drug
safety and efficacy in pregnancy. Moreover, changes in the maternal physiology in pregnancy
often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a highly
efficacious artemisinin-based combination therapy approved by the World Health Organisation
for use in the 2nd and 3rd trimesters, although it is still infrequently used in pregnancy
and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN are altered in
pregnancy, resulting in reduced plasma concentrations and while the standard adult dose is
still effective in high transmission settings, where pregnant women have higher levels of
immunity, efficacy is reduced significantly in low transmission settings where women have
lower levels of immunity. Inadequate antimalarial treatment dosing in pregnancy risks
treatment failure or breakthrough infection and exposure of malaria parasites to
sub-therapeutic drug concentrations thus selecting for drug resistance.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborator:
University of Kinshasa
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Lumefantrine