Comparison of intermittent screening and treatment (using Pyramax®) to standard intermittent preventive treatment with sulphadoxine-pyrimethamin for the prevention of malaria in pregnant women living in endemic areas

In endemic settings Plasmodium falciparum (Pf) can undergo sequestration in the placenta, resulting in low peripheral parasitemia and false negative diagnostic malaria in pregnant women. The Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization’s recommended malaria control strategies in sub-Saharan African countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by treating them all with SP under pre-determined schedules. However, IPTp-SP is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, the Intermittent Screening and Treatment in pregnancy (ISTp) which comprises monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and treatment of positive cases with an artemisinin-based combination therapy (ACT) without consideration of symptoms. However, ISTp closely depends on the performance of diagnostic tests and the effectiveness of the ACT. In endemic settings, standard malaria RDTs waned sensitivity because of the occurrence of the Pf histidine-rich protein 2/3 (PfHRP2/3) gene deletion in Pf. A study comparing ISTp and IPTp-SP conducted to conflicting results, perhaps for difference of transmission settings and low sensitivities of standard RDTs. Using ultrasensitive RDTs (us-RDT) should be able to overcome the latter limitation. Compared with IPTp-SP, ISTp has the advantage to prevent the overuse of antimalarial and thus limits the drug pressure on malaria parasites. However, to further limit the pressure, the ideal ACT for the strategy would be one that is not yet used or planned to be used in the field for other malaria control strategies like Pyronaridine-Artesunate(Pyramax®), a newly registered antimalarial. This study will compare the efficacy of the ISTp strategy using an us-RDT and Pyramax® (ISTp-US-Py) with the IPTp-SP strategy through a randomized clinical trial conducted from the second trimester of pregnancy among women of Mont Ngafula1, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area. Study indicators will be malaria, anemia, spontaneous abortions or intrauterine deaths during pregnancy, and, fetal morbidity (preterm birth, low-birth-weight, small for gestational age) and neonatal mortality at delivery in the groups of pregnant women who will monthly experiment ISTp-US-Py compared to those who will receive IPTp-SP as recommended by the National Malaria Control Program (NMCP). The results generated from this study will be primal for the NMCP in the selection and implementation of new malaria control policies to address the effectiveness of IPTp-SP decline among pregnant women in the DRC.

Project details

Drug Resistance
Vulnerable Populations

Oct 2020 — Sep 2023

$171,000

Dem. Rep. of Congo