Comparison of intermittent screening (using ultra-sensitive malaria Rapid Diagnostic test) and treatment (using a newly registered antimalarial Pyronaridine - Artesunate – PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas. ULTRAPYRAPREG

Abstract

Background Intermittent Preventive Treatment in pregnancy (IPTp) with Sulfadoxine-Pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on predetermined schedules. However, over time, the spread of Plasmodium resistant strains has threaten this strategy in many countries. As an alternative, the Intermittent Screening and Treatment for pregnancy (ISTp) aims at a monthly screening of pregnant women, preferably by using very sensitive tests such as ultrasensitive rapid diagnostic tests (us-RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. Unlike IPTp-SP, ISTp prevents overuse of antimalarials limiting the drug pressure on parasites, an advantage which can be potentiated by using an ACT like Pyronaridine - Artesunate (Pyramax®) that is not yet used in pregnant women in the field. Methods This study aims to compare the non-inferiority of ISTp using us-RDTs and Pyramax® versus IPTp-SP on malaria in pregnancy through a randomized clinical trial performed in Kisenso, Kinshasa, the Democratic Republic of the Congo, a malaria perennial transmission area. Discussion The results will be essential for the National Malaria Control Program to update malaria prevention policy in pregnant women in the Democratic Republic of the Congo. Trial registration: ClinicalTrials.gov ID: NCT04783051