Efficacy,Safety and Tolerability of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Pregnancy in Ghana
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy poses enormous public health challenges, contributing to significant
maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low
birthweight. Down regulation of cellular immunity increases pregnant women's susceptibility
to malaria and mediate these adverse outcomes.
The World Health Organization recommends treatment with artemisinin-combination therapy.
Ghana uses quinine for malaria in first trimester pregnancies while artesunate-amodiaquine
(AS-AQ) and quinine again are used in later trimesters. Recent amendments added
artesunate-lumefantrine and dihydroartemisinin-piperaquine (DHA-PPQ) to the antimalarials
used in the country. A high degree of safety and efficacy of DHA-PPQ is documented in several
studies. DHA-PPQ, though not specified for use in pregnancy as of now, is accessible and
available following its inclusion in the national malaria guidelines and may inadvertently be
used to treat malaria in pregnancy. Paucity of data on DHA-PPQ use in pregnancy makes it
pertinent to study its safety, tolerability and efficacy in pregnancy.
We propose an open label, randomized controlled non-inferiority comparison of DHA-PPQ and
AS-AQ for treatment of uncomplicated malaria in pregnancy in second and third trimesters to
assess safety, tolerability and efficacy of DHA-PPQ. Outcomes of interest include
PCR-corrected cure rates at days 28 and 42, maternal haemoglobin levels at days 14 and 42,
prevalence of congenital abnormalities and pregnancy wastage. Proportions and percentages
will be described at 95% Confidence Intervals and compared using chi-square tests. Parametric
and non-parametric tests of significance will be applied as appropriate to determine
significance of differences in outcomes between the treatment groups.
Phase:
Phase 3
Details
Lead Sponsor:
Kwame Nkrumah University of Science and Technology