Plasmodium Falciparum Malaria Clinical Trial
— ASSERMalariaOfficial title:
Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight
Verified date | March 2023 |
Source | Institut de Recherche en Sciences de la Sante, Burkina Faso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 340 |
Est. completion date | December 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro | Ouagadougou | Kadiogo |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherche en Sciences de la Sante, Burkina Faso | European and Developing Countries Clinical Trials Partnership (EDCTP) |
Burkina Faso,
COSMIC Consortium. Community-based Malaria Screening and Treatment for Pregnant Women Receiving Standard Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: A Multicenter (The Gambia, Burkina Faso, and Benin) Cluster-randomized Controlled Trial. Clin Infect Dis. 2019 Feb 1;68(4):586-596. doi: 10.1093/cid/ciy522. — View Citation
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Hofmann NE, Gruenberg M, Nate E, Ura A, Rodriguez-Rodriguez D, Salib M, Mueller I, Smith TA, Laman M, Robinson LJ, Felger I. Assessment of ultra-sensitive malaria diagnosis versus standard molecular diagnostics for malaria elimination: an in-depth molecular community cross-sectional study. Lancet Infect Dis. 2018 Oct;18(10):1108-1116. doi: 10.1016/S1473-3099(18)30411-0. Epub 2018 Aug 28. — View Citation
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van Eijk AM, Hill J, Larsen DA, Webster J, Steketee RW, Eisele TP, ter Kuile FO. Coverage of intermittent preventive treatment and insecticide-treated nets for the control of malaria during pregnancy in sub-Saharan Africa: a synthesis and meta-analysis of national survey data, 2009-11. Lancet Infect Dis. 2013 Dec;13(12):1029-42. doi: 10.1016/S1473-3099(13)70199-3. Epub 2013 Sep 18. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Placental malaria prevalence | The prevalence of placental malaria infection will be determined in the two arms. Placentas will be identified as not infected (no evidence of parasite or pigment); active infection (presence of parasites and pigment) and chronic infection (absence of parasites and presence of pigment) | 36 months | |
Primary | Low birthweight prevalence | The prevalence of low birthweight (defined as birth weight less than 2,500 g) will be compared between the two arms. | 36 months | |
Primary | Peripheral maternal malaria infection prevalence | At delivery, malaria will be diagnosed using peripheral thick smears. Parasite density will be estimated by counting the number of asexual parasites per 200 leukocytes in the thick blood film and assuming white blood cells (WBC) count of 8,000/µl | 36 months |
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