Maternal health
Does a 3-day malaria combination pill work well in pregnancy?
Open access · cc by · source: Europe PMC
In pregnant women on the Thai-Burmese border, the standard 3-day artemether-lumefantrine course was safe but cured fewer malaria infections than 7 days of artesunate, probably because pregnancy lowers drug levels.
Study at a glance
- Design
- RCT — Open-label randomised trial with concealed allocation: 3-day artemether-lumefantrine vs 7-day artesunate, all doses directly observed; follow-up to delivery or day 42 and infants to 1 year
- N
- N=253 · 253 episodes of falciparum malaria in 252 pregnant women (125 artemether-lumefantrine, 128 artesunate; one woman randomised twice); day 7 lumefantrine levels measured in 85
- Population
- Karen and Burmese pregnant women in the second or third trimester with uncomplicated P. falciparum malaria attending antenatal clinics on the Thai-Burmese border
- Outcome
- Primary: PCR-adjusted parasitological cure at delivery or day 42 (whichever later); secondary: fever/parasite clearance, anaemia, adverse events, birth outcomes, infant growth and development to 1 year
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Key findings
Artesunate cured more infections than artemether-lumefantrine; after censoring women who got P. vivax, cure rates were 92.2% versus 83.8% (p = 0.045), and both regimens fell below the WHO 90% benchmark in the main analysis. The gap came mainly from women entering with a recrudescent infection, while cure rates for new or first infections were similar. Nearly a third of recrudescences appeared after day 42, and every woman with day 7 lumefantrine above 600 ng/ml was cured versus 22% failure below that. Both drugs were well tolerated, with no differences in birth weight, gestation, congenital abnormalities or infant development.
Methodology
Pregnant women in their second or third trimester with uncomplicated falciparum malaria were randomly assigned, via sealed envelopes, to the standard six-dose, 3-day artemether-lumefantrine course or to artesunate once daily for 7 days, with every dose supervised in hospital. Women were checked weekly until delivery (or day 42 if later), and PCR genotyping distinguished true treatment failures (recrudescence) from new infections. Babies were examined at birth and followed for growth and development to 1 year, and day 7 blood lumefantrine levels were measured in a subgroup.
Limitations
Treatment was open-label because the regimens looked so different, although lab staff reading slides and PCR were blinded. The subgroup result on recrudescent infections was an exploratory analysis the trial was not designed for, and early recruitment was restricted to recurrent infections by an ethics committee. It was set in a low-transmission, multidrug-resistant area, so the authors caution that AL may work better where women have more immunity. The trial was not powered to detect differences in birth outcomes, and the higher infant death rate in the artesunate group was judged unrelated to treatment.
How this study connects
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