Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of
Female
Humans
Infant
Pregnancy
Antimalarials
/ adverse effects
Artemether
/ therapeutic use
Artemether, Lumefantrine Drug Combination
/ therapeutic use
Artemisinins
/ adverse effects
Clinical Trials, Phase III as Topic
Drug Combinations
Malaria
/ drug therapy
Malaria, Falciparum
/ drug therapy
Pregnant Women
Randomized Controlled Trials as Topic
Treatment Outcome
Sub-Saharan African People
epidemiology
infection control
parasitology
tropical medicine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
09 10 2023
09 10 2023
Historique:
medline:
13
10
2023
pubmed:
12
10
2023
entrez:
9
10
2023
Statut:
epublish
Résumé
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 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. 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. PACTR202011812241529.
Identifiants
pubmed: 37813539
pii: bmjopen-2022-065295
doi: 10.1136/bmjopen-2022-065295
pmc: PMC10565244
doi:
Substances chimiques
Antimalarials
0
Artemether
C7D6T3H22J
Artemether, Lumefantrine Drug Combination
0
artemisinin
9RMU91N5K2
Artemisinins
0
artenimol
6A9O50735X
Drug Combinations
0
pyronaridine tetraphosphate, artesunate drug combination
0
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e065295Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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