Additional Screening With Sensitives RDTs and Malaria

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For the latter, 3 or more doses are recommended by the national malaria control program (NMCP) but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by perceptions, acceptability and contextual factors that need to be understood and therefore improve the effectiveness of this health interventions. In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many malaria cases are missed in pregnant women due to the power performance of recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT could improve the outcome of the pregnancy in addition to IPTp-SP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Collaborator: European and Developing Countries Clinical Trials Partnership (EDCTP)
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin

Criteria

Inclusion Criteria:

• Gestational age of 16 to 24 weeks at their first booking

• At least (≥) 16 years old

• Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery

• Willing to deliver at the health facility

• Willing to provide biological samples as and when required during the study period (blood and placental biopsy)

• Ability to provide written informed consent

Exclusion Criteria:

• A history of sensitivity to sulphonamides or to any of the study drugs;

• History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;

• History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;

• Any significant illness at the time of screening that requires hospitalization, including severe malaria;

• Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.

• Prior enrolment in the study or concurrent enrolment in another study.