Administrative information
Title {1} | 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. ULTRAPYRAPREG |
Trial registration {2a and 2b}. | ClinicalTrials.gov ID: NCT04783051 |
Protocol version {3} | Upyrapreg_ paper draft Version 1.2_ 08042022 |
Funding {4} | This project is a part of the EDCTP2 program supported by European Union (Grant number TMA2019CDF-2699-ULTRAPYRAPREG) and Novartis. |
Author details {5a} | Vivi Maketa1, Japhet Kabalu1,2, Melissa Kabena1, Flory Luzolo1, Hypolite Muhindo-Mavoko1, Henk D. F. H. Schallig2, Kassoum Kayentao3, Petra F. Mens2, Pascal Lutumba1, Halidou Tinto4 Author’s Affiliations: 1 Department of Tropical Medicine, University of Kinshasa (UNIKIN), Kinshasa, Democratic Republic of the Congo 2 Amsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam (AMC), Laboratory for Experimental Parasitology, Amsterdam Institute for Infection and Immunology, Amsterdam, Netherlands 3 Malaria Research and Training Center (MRTC), University of Sciences of Techniques and Technologies of Bamako (USTTB), Mali 4 Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN), Burkina Faso. |
Name and contact information for the trial sponsor {5b} | University of Kinshasa Rector : Jean Marie Kayembe Ntumba jm.kayembe@unikin.ac.cd |
Role of sponsor {5c} | The role of the sponsor is to design and perform the clinical trial, to analyze and interpret data, and ensure the results dissemination through reports and publication. The funders’ aim is to provide the funds necessary for all the activities in the field but they had no role in study design or field data collection. The funders will not be involved in the analyses or interpretation of the data. |
Introduction
Background and rationale {6a}
Objectives {7}
Main objective
Secondary objectives
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The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP
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The proportion of the parasite densities is not higher when using ISTp-US-Py compared to IPTp-SP
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The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP
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The incidence of spontaneous abortions or intrauterine deaths is not higher when using ISTp-US-Py compared to IPTp-SP
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The proportion of asymptomatic/symptomatic malaria cases is not higher when using ISTp-US-Py compared to IPTp-SP
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The parasite densities are not higher when using ISTp-US-Py compared to IPTp-SP
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The proportion of anemia is not higher when using ISTp-US-Py compared to IPTp-SP
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Intrauterine death
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The fetal morbidities (preterm birth, low birth weight) are not higher when using ISTp-US-Py compared to IPTp-SP
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The neonatal and early neonatal mortality of the offspring is not higher when using ISTp-US-Py compared to IPTp-SP
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions {6b}
Explanation for the choice of comparators
Intervention description {11a}
Concomitant therapies
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Enrolment | Allocation | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Timepoint** | -t1 | 0 | M1 | M2 | M3 | M4 | M5 | M6 | Delivery | 4–6 weeks post-end of pregnancy |
Enrolment | ||||||||||
Eligibility screen | X | |||||||||
Informed consent | X | |||||||||
Allocation | X | |||||||||
Interventions | ||||||||||
IPTp-SP | X | X | X | X | X | X | ||||
ISTp | X | X | X | X | X | X | ||||
Assessments | ||||||||||
Mother | ||||||||||
Temperature | X | X | X | X | X | X | X | |||
Thick smear | X | X | X | X | X | X | X | |||
TDR, US-TDR | X | X | X | X | X | X | X | |||
Hb | X | X | X | X | X | X | X | |||
Mother | ||||||||||
Temperature | X | X | X | X | X | X | X | |||
Thick smear | X | X | X | X | X | X | X | |||
TDR, US-TDR | X | X | X | X | X | X | X | |||
Hb | X | X | X | X | X | X | X | |||
Offspring | ||||||||||
Weight, temperature | X | |||||||||
APGAR | X | |||||||||
Thick smear | X | |||||||||
Hb | X | |||||||||
Newborn assessment | X |
Sample size {14}
IPTp | IST | Sample size | |
---|---|---|---|
Low birth weight | 10.5 | 15.7 | 122 |
Malaria infection | 18.9 | 23.4 | 196 |
Anemia | 30 | 25 | 220 |
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
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PCR
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Malaria diagnostic