Harry Tagbor 1 , 2 , Matthew Cairns 1 , Kalifa Bojang 3 , Sheick Oumar Coulibaly 4 , Kassoum Kayentao 5 , John Williams 6 , Ismaela Abubakar 3 , Francis Akor 3 , Khalifa Mohammed 3 , Richard Bationo 4 , Edgar Dabira 4 , Alamissa Soulama 4 , Moussa Djimdé 5 , Etienne Guirou 5 , Timothy Awine 6 , Stephen Quaye 6 , Fanta Njie 3 , Jaume Ordi 7 , Ogobara Doumbo 5 , Abraham Hodgson 6 , Abraham Oduro 6 , Steven Meshnick 8 , Steve Taylor 9 , Pascal Magnussen 10 , Feiko ter Kuile 11 , Arouna Woukeu 1 , Paul Milligan 1 , Daniel Chandramohan 1 , Brian Greenwood 1 , *
10 August 2015
The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.
An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.
Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.