Evidence map›Paper›PMID 26962728›Full record

Trial reportThe New England journal of medicine2016

Dihydroartemisinin-Piperaquine for the Prevention of Malaria in Pregnancy.

Abel Kakuru, Prasanna Jagannathan, Mary K Muhindo, Paul Natureeba, Patricia Awori, Miriam Nakalembe, Bishop Opira, Peter Olwoch, John Ategeka, Patience Nayebare and 8 more

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 151 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 12 pooled it
27.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02163447 phase3completednot on this map

Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 1)

TypeinterventionalSponsorGrant Dorsey, M.D, Ph.D.Ran2014 to 2018Enrolled300ConditionsMalariaArmsMonthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy, Monthly dihydroartemisinin-piperaquine (DP) for infants, 3-monthly dihydroartemisinin-piperaquine (DP) for infants
NCT04147546 phase3completednot on this mapstarted 2020, after this paper: background citation

Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight

TypeinterventionalSponsorInstitut de Recherche en Sciences de la Sante, Burkina FasoRan2020 to 2021Enrolled340ConditionsPlasmodium Falciparum Malaria, Malaria DiagnosisArmsAdditional screening using ultra sensitive RDTs, Dihydroartemisinin-piperaquin, Reminders
NCT05757167 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

TypeinterventionalSponsorDuke UniversityRan2023 to 2026Enrolled2,174ConditionsMalaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, PregnancyArmsMalaria High-Sensitivity Rapid Diagnostic Test (HS-RDT), Artemether-lumefantrine (AL)
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 12 syntheses or guidelines pooled it, 233 citations in OpenAlex.

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91 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Abel KakuruFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Prasanna JagannathanFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Mary K MuhindoFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Paul NatureebaFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Patricia AworiFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Miriam NakalembeFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Bishop OpiraFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Peter OlwochFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
John AtegekaFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Patience NayebareFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Tamara D ClarkFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Margaret E FeeneyFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Edwin D CharleboisFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Gabrielle RizzutoFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Atis MuehlenbachsFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Diane V HavlirFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Moses R KamyaFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Grant DorseyFrom the Infectious Diseases Research Collaboration (A.K., M.K.M., P. Natureeba, P.A., B.O., P.O., J.A., P. Nayebare), the Department of Obstetrics and Gynecology, Makerere University College of Health Sciences (M.N.), and the School of Medicine, Makerere University College of Health Sciences (M.R.K.) - all in Kampala, Uganda; the Departments of Medicine (P.J., T.D.C., M.E.F., D.V.H., G.D.), Pediatrics (M.E.F.), and Pathology (G.R.) and the Center for AIDS Prevention Studies (E.D.C.), University of California, San Francisco, San Francisco; and the Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta (A.M.).
Makerere University · UG

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Sheri Ann Lippman · 2001 to 2026
$57.4M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
The immunologic consequences of prenatal exposure to malariaP01HD059454 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DORSEY, MATTHEW G · 2008 to 2017
$22.6M
The role of γδ T cells in fetal and infant immune defense against malariaR01AI093615 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI FEENEY, MARGARET E · 2011 to 2025
$9.1M
Mentoring Translational Researchers for Careers in Pediatric Global HealthK24AI113002 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI FEENEY, MARGARET E · 2014 to 2023
$1.9M
Immunologic Consequences of Highly Effective Antimalarial ChemopreventionK23AI100949 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JAGANNATHAN, PRASANNA · 2012 to 2016
$657k
NIAID NIH HHS K23 AI100949NIAID NIH HHS K24 AI113002NIAID NIH HHS R01 AI093615NIAID NIH HHS UM1 AI069496NICHD NIH HHS P01 HD059454NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

backgroundIntermittent treatment with sulfadoxine-pyrimethamine is widely recommended for the prevention of malaria in pregnant women in Africa. However, with the spread of resistance to sulfadoxine-pyrimethamine, new interventions are needed.

methodsWe conducted a double-blind, randomized, controlled trial involving 300 human immunodeficiency virus (HIV)-uninfected pregnant adolescents or women in Uganda, where sulfadoxine-pyrimethamine resistance is widespread. We randomly assigned participants to a sulfadoxine-pyrimethamine regimen (106 participants), a three-dose dihydroartemisinin-piperaquine regimen (94 participants), or a monthly dihydroartemisinin-piperaquine regimen (100 participants). The primary outcome was the prevalence of histopathologically confirmed placental malaria.

resultsThe prevalence of histopathologically confirmed placental malaria was significantly higher in the sulfadoxine-pyrimethamine group (50.0%) than in the three-dose dihydroartemisinin-piperaquine group (34.1%, P=0.03) or the monthly dihydroartemisinin-piperaquine group (27.1%, P=0.001). The prevalence of a composite adverse birth outcome was lower in the monthly dihydroartemisinin-piperaquine group (9.2%) than in the sulfadoxine-pyrimethamine group (18.6%, P=0.05) or the three-dose dihydroartemisinin-piperaquine group (21.3%, P=0.02). During pregnancy, the incidence of symptomatic malaria was significantly higher in the sulfadoxine-pyrimethamine group (41 episodes over 43.0 person-years at risk) than in the three-dose dihydroartemisinin-piperaquine group (12 episodes over 38.2 person-years at risk, P=0.001) or the monthly dihydroartemisinin-piperaquine group (0 episodes over 42.3 person-years at risk, P<0.001), as was the prevalence of parasitemia (40.5% in the sulfadoxine-pyrimethamine group vs. 16.6% in the three-dose dihydroartemisinin-piperaquine group [P<0.001] and 5.2% in the monthly dihydroartemisinin-piperaquine group [P<0.001]). In each treatment group, the risk of vomiting after administration of any dose of the study agents was less than 0.4%, and there were no significant differences among the groups in the risk of adverse events.

conclusionsThe burden of malaria in pregnancy was significantly lower among adolescent girls or women who received intermittent preventive treatment with dihydroartemisinin-piperaquine than among those who received sulfadoxine-pyrimethamine, and monthly treatment with dihydroartemisinin-piperaquine was superior to three-dose dihydroartemisinin-piperaquine with regard to several outcomes. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT02163447.).

Indexed as

AdolescentAdultAntimalarialsArtemisininsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsDrug ResistanceFemaleHumansIncidenceMalariaParasitemiaPiperazinesPregnancyPregnancy Complications, ParasiticAntimalarialsArtemisininsartenimolDrug Combinationsfanasil, pyrimethamine drug combinationpiperaquinePiperazinesPyrimethamineQuinolinesSulfadoxine

Identifiers

PMID26962728
PMCPMC4847718
OpenAlexW2294130235

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.