TY - JOUR
T1 - 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
T2 - ULTRAPYRAPREG
AU - Maketa, Vivi
AU - Kabalu, Japhet
AU - Kabena, Melissa
AU - Luzolo, Flory
AU - Muhindo-Mavoko, Hypolite
AU - Schallig, Henk D. F. H.
AU - Kayentao, Kassoum
AU - Mens, Petra F.
AU - Lutumba, Pascal
AU - Tinto, Halidou
N1 - Funding Information: The authors thank Shinpoong Pharm.co., LTd, for providing the study drug (pyronaridine-artesunate: Pyramax®); the other study staff for contributing to the collection of data in the field; and the local health authorities of Maternité Esengo. VM and HT conceptualized the idea. VM, HM, and JK wrote the study protocol. HS, PL, PM, KK, and HT reviewed the protocol. MK, JK, and FL contributed to the essential document writing. VM and JK did the approval procedures of the protocol by ethical committees and regulatory authorities. MK, FL, PL, HM, VM, and JK implemented the study protocol in the field. All authors read and approved the submitted manuscript. All the authors cited above will be part of the subsequent publications that will result from this study protocol and will be acknowledged according to the role and contribution they will make. This project is a part of the EDCTP2 program supported by the European Union (Grant number TMA2019CDF-2699-ULTRAPYRAPREG) and Novartis. This study is embedded on the Pyrapreg clinical trial Grant Ref. RIA2017MC-2025 – PYRAPREG (PACTR202011812241529). The study is registered at ClinicalTrials.gov , number: NCT04783051. All the elements detailed in the registration on the site at ClinicalTrials.gov site are part of this protocol. The case report forms, data from the source document, and samples related to this study will be the property of the University of Kinshasa; however, all the consortium partners will have access to the data collected on demand. Funding Information: This project is a part of the EDCTP2 program supported by the European Union (Grant number TMA2019CDF-2699-ULTRAPYRAPREG) and Novartis. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed, it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on predetermined schedules. However, over time, the spread of Plasmodium-resistant strains has threatened this strategy in many countries. As an alternative, the intermittent screening and treatment for pregnancy (ISTp) aims at a monthly screening of pregnant women, preferably by using very sensitive tests such as ultrasensitive rapid diagnostic tests (us-RDTs) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. Unlike IPTp-SP, ISTp prevents overuse of antimalarials limiting the drug pressure on parasites, an advantage which can be potentiated by using an ACT like pyronaridine-artesunate (Pyramax®) that is not yet used in pregnant women in the field. Methods: This study aims to compare the non-inferiority of ISTp using us-RDTs and Pyramax® versus IPTp-SP on malaria in pregnancy through a randomized clinical trial performed in Kisenso, Kinshasa, the Democratic Republic of the Congo, a malaria perennial transmission area. Discussion: The results will be essential for the National Malaria Control Program to update the malaria prevention policy in pregnant women in the Democratic Republic of the Congo. Trial registration: ClinicalTrials.gov NCT04783051.
AB - Background: Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed, it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on predetermined schedules. However, over time, the spread of Plasmodium-resistant strains has threatened this strategy in many countries. As an alternative, the intermittent screening and treatment for pregnancy (ISTp) aims at a monthly screening of pregnant women, preferably by using very sensitive tests such as ultrasensitive rapid diagnostic tests (us-RDTs) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. Unlike IPTp-SP, ISTp prevents overuse of antimalarials limiting the drug pressure on parasites, an advantage which can be potentiated by using an ACT like pyronaridine-artesunate (Pyramax®) that is not yet used in pregnant women in the field. Methods: This study aims to compare the non-inferiority of ISTp using us-RDTs and Pyramax® versus IPTp-SP on malaria in pregnancy through a randomized clinical trial performed in Kisenso, Kinshasa, the Democratic Republic of the Congo, a malaria perennial transmission area. Discussion: The results will be essential for the National Malaria Control Program to update the malaria prevention policy in pregnant women in the Democratic Republic of the Congo. Trial registration: ClinicalTrials.gov NCT04783051.
KW - IPTp-SP
KW - ISTp
KW - Malaria
KW - Malaria indicators
KW - Pregnancy
KW - Ultra-sensitive RDTs
UR - http://www.scopus.com/inward/record.url?scp=85142821834&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06884-8
DO - https://doi.org/10.1186/s13063-022-06884-8
M3 - Article
C2 - 36443882
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 963
ER -