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Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of uncomplicated malaria in African pregnant women (PYRAPREG): study protocol for a phase 3, non-inferiority, randomised open-label clinical trial. | LitMetric

AI Article Synopsis

  • Malaria during pregnancy raises risks of low birth weight and infant mortality, with the study focusing on comparing the efficacy and safety of a new drug, pyronaridine-artesunate (PA), against established treatments artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP).
  • Conducted in five sub-Saharan countries, this phase 3 clinical trial will enroll 1,875 pregnant women, monitoring their health for 63 days post-treatment and assessing infants' health at one year old.
  • The study has received ethical approvals from several committees across different countries, and informed consent will be acquired from participants, with results expected to be published in open access journals.

Article Abstract

Introduction: Malaria infection during pregnancy increases the risk of low birth weight and infant mortality and should be prevented and treated. Artemisinin-based combination treatments are generally well tolerated, safe and effective; the most used being artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP). Pyronaridine-artesunate (PA) is a new artemisinin-based combination. The main objective of this study is to determine the efficacy and safety of PA versus AL or DP when administered to pregnant women with confirmed infection in the second or third trimester. The primary hypothesis is the pairwise non-inferiority of PA as compared with either AL or DP.

Methods And Analysis: A phase 3, non-inferiority, randomised, open-label clinical trial to determine the safety and efficacy of AL, DP and PA in pregnant women with malaria in five sub-Saharan, malaria-endemic countries (Burkina Faso, Democratic Republic of the Congo, Mali, Mozambique and the Gambia). A total of 1875 pregnant women will be randomised to one of the treatment arms. Women will be actively monitored until Day 63 post-treatment, at delivery and 4-6 weeks after delivery, and infants' health will be checked on their first birthday. The primary endpoint is the PCR-adjusted rate of adequate clinical and parasitological response at Day 42 in the per-protocol population.

Ethics And Dissemination: This protocol has been approved by the Ethics Committee for Health Research in Burkina Faso, the National Health Ethics Committee in the Democratic Republic of Congo, the Ethics Committee of the Faculty of Medicine and Odontostomatology/Faculty of Pharmacy in Mali, the Gambia Government/MRCG Joint Ethics Committee and the National Bioethics Committee for Health in Mozambique. Written informed consent will be obtained from each individual prior to her participation in the study. The results will be published in peer-reviewed open access journals and presented at (inter)national conferences and meetings.

Trial Registration Number: PACTR202011812241529.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565244PMC
http://dx.doi.org/10.1136/bmjopen-2022-065295DOI Listing

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