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Malaria parasite resistance to sulfadoxine-pyrimethamine (SP) threatens its effectiveness for intermittent preventive treatment (IPT) during pregnancy. To assess the safety and efficacy of alternative strategies, investigators conducted a multisite, open-label, controlled superiority trial in western Kenya, where levels of malaria transmission and SP resistance are high.
A total of 1546 HIV-negative pregnant women (16–32 weeks' gestation) were randomized to receive intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine (DP), IPT with DP, or IPT with SP (currently, the WHO-recommended regimen).
Participants received their allocated study intervention at enrollment and at each follow-up visit, at 4- to 6-week intervals. The prevalence of malaria infection at delivery — the primary study endpoint — was 3% in the IPT/DP group versus 10% in the IPT/SP group and 13% in the IST/DP group. Compared with IPT/SP, IPT/DP was associated with a 68% decrease in malaria infection at delivery and an 84% decrease in clinical malaria incidence during pregnancy. Risk for stillbirth was also lower in the IPT/DP group, but mean birth weight was higher in the IPT/SP group, despite similar gestational age at delivery.
Desai M et al. Intermittent screening and treatment or intermittent preventive treatment with dihydroartemisinin-piperaquine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for the control of malaria during pregnancy in western Kenya: An open-label, three-group, randomised controlled superiority trial. Lancet 2015 Sep 28; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(15)00310-4)
Chico RM and Moss WJ.Prevention of malaria in pregnancy: A fork in the road? Lancet 2015 Sep 28; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(15)00325-6)
Comment
By most measures, outcomes were better with IPT/DP than with IPT/SP; however, IPT/DP was not better in reducing risk for low birth weight or preterm birth. The authors postulate that IPT/DP may have prevented fetal loss in borderline pregnancies, resulting in more low–birth weight live births. The authors and editorialists observe that SP has broad antimicrobial activity, as well as antimalarial activity, and might have treated or prevented unrecognized bacterial or parasitic infections. Future studies might assess the combined effect of DP and a broad-spectrum antimicrobial, such as azithromycin. IST was not superior to IPT in this trial, but the rapid diagnostic test used for screening may have been inadequate to detect asymptomatic, low-density malarial infections.