Malaria in Pregnancy Clinical Trial
Official title:
Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.
Malaria is the most important human parasitic disease. Although pregnant women are a
high-risk group, they are almost systematically excluded from clinical trials, for fear of
teratogenicity and embryotoxicity; thus, we generally lack sufficient information on the
safety and efficacy of most antimalarials in pregnancy, as well as evidence-based
recommendations for the prevention and treatment of malaria during pregnancy.
The WHO recommendation to use artemisinin combination therapy (ACT) in the 2nd and 3rd
trimester is already implemented in several African countries. However, the documentation of
their efficacy and safety in pregnancy is still limited, especially concerning the African
contexts.
Therefore, we propose to test 4 fixed-dose combinations (artemether-lumefantrine,
amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), to
evaluate their efficacy and safety when administered to pregnant women (2nd and 3rd
trimester) infected with P. falciparum. Explanatory variables will be collected for
treatment failure (PCR-corrected) and for recurrent parasitaemia. The primary hypothesis
tested will be the clinical equivalence (pair-wise non-inferiority) of the 4 treatment
regimens with clinical equivalence defined as difference in treatment failure rates (PCR
corrected) of 5% or less.
In addition, an attempt will be done to carry out in vitro testing at the time of recurrent
infection. However, the success of the test will depend on the parasite density. In
addition, blood samples collected on filter paper at day 0 and at day of recurrent
parasitaemia will be genotyped for the search of known molecular markers related to drug
resistance. Not all samples will be analyzed; rather these will be selected according to the
therapeutic response so that the prevalence of molecular markers will be compared between
treatment successes, true treatment failures and new infections.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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