Project Title

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)

EDCTP Project Call

Career Development Fellowship (CDF)

Project Objectives

Main objective The main objective is to assess that the proportion of maternal malaria, maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity and neonatal mortality at childbirth is non inferior when using ISTp-US-Py compared to IPTp-SP. Secondary objective The secondary objectives are to assess that: During pregnancy: - The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of parasitic densities is not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP - The incidence of spontaneous abortions or intrauterine deaths is not higher when using ISTp-US-Py compared to IPTp-SP After the birth: In women: - The proportion symptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP - The parasitic densities are not higher when using ISTp-US-Py compared to IPTp-SP - The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP In the offspring: - Intrauterine death - The fetal morbidities (Preterm birth, Low-birth-weight) are not higher when using C compared to IPTp-SP During the 28 days period following the birth: - The neonatal and early neonatal mortality of the offspring are not higher when using ISTp-US-Py compared to IPTp-SP

Study Design

This is a 2 arms 1.1 ratio randomized non-inferiority trial. An unique registration number will be associated with a randomization list number, generated before the start of the study and which will determine the assignment of the study participant to one of the study groups. - The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with us-RDT and who will be treated with Pyramax® if the test is positive. - The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy.

Project Summary

In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-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 according to predetermined schedules, but the strategy is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional RDTs, should improve the efficacy of the strategy. Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT that is not yet used or should not be used in the field for other strata of the population. The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal candidate for this purpose. This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py) with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy, fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal mortality at delivery in both study groups through conducting a randomized clinical trial enrolling second trimester pregnant women in Maternité Esengo Health Center, located in Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area. The results generated from this study will be essential for the National Malaria Control Program in the selection and implementation of new malaria control policies and addresses the effectiveness of IPTp-SP decline among pregnant women in the DRC.

Host Organisation

Sites

Current Organisation

UNIKIN

Current Job Title

Lecturer

Biography

Publications