A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
Identifieur interne : 000024 ( Pmc/Curation ); précédent : 000023; suivant : 000025A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
Auteurs : Harry Tagbor [Royaume-Uni, Ghana] ; Matthew Cairns [Royaume-Uni] ; Kalifa Bojang [Gambie] ; Sheick Oumar Coulibaly [Burkina Faso] ; Kassoum Kayentao [Mali] ; John Williams [Ghana] ; Ismaela Abubakar [Gambie] ; Francis Akor [Gambie] ; Khalifa Mohammed [Gambie] ; Richard Bationo [Burkina Faso] ; Edgar Dabira [Burkina Faso] ; Alamissa Soulama [Burkina Faso] ; Moussa Djimdé [Mali] ; Etienne Guirou [Mali] ; Timothy Awine [Ghana] ; Stephen Quaye [Ghana] ; Fanta Njie [Gambie] ; Jaume Ordi [Espagne] ; Ogobara Doumbo [Mali] ; Abraham Hodgson [Ghana] ; Abraham Oduro [Ghana] ; Steven Meshnick [États-Unis] ; Steve Taylor [États-Unis] ; Pascal Magnussen [Danemark] ; Feiko Ter Kuile [Royaume-Uni] ; Arouna Woukeu [Royaume-Uni] ; Paul Milligan [Royaume-Uni] ; Daniel Chandramohan [Royaume-Uni] ; Brian Greenwood [Royaume-Uni]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.
An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.
Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.
ClinicalTrials.gov
Pan African Clinical trials Registry
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DOI: 10.1371/journal.pone.0132247
PubMed: 26258474
PubMed Central: 4530893
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Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Awine, Timothy" sort="Awine, Timothy" uniqKey="Awine T" first="Timothy" last="Awine">Timothy Awine</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Quaye, Stephen" sort="Quaye, Stephen" uniqKey="Quaye S" first="Stephen" last="Quaye">Stephen Quaye</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health 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Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Doumbo, Ogobara" sort="Doumbo, Ogobara" uniqKey="Doumbo O" first="Ogobara" last="Doumbo">Ogobara Doumbo</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Hodgson, Abraham" sort="Hodgson, Abraham" uniqKey="Hodgson A" first="Abraham" last="Hodgson">Abraham Hodgson</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Oduro, Abraham" sort="Oduro, Abraham" uniqKey="Oduro A" first="Abraham" last="Oduro">Abraham Oduro</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Meshnick, Steven" sort="Meshnick, Steven" uniqKey="Meshnick S" first="Steven" last="Meshnick">Steven Meshnick</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC</wicri:regionArea></affiliation></author><author><name sortKey="Taylor, Steve" sort="Taylor, Steve" uniqKey="Taylor S" first="Steve" last="Taylor">Steve Taylor</name><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Duke University Medical Center, Durham, NC, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Duke University Medical Center, Durham, NC</wicri:regionArea></affiliation></author><author><name sortKey="Magnussen, Pascal" sort="Magnussen, Pascal" uniqKey="Magnussen P" first="Pascal" last="Magnussen">Pascal Magnussen</name><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>(Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen, Denmark</addr-line></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>(Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen</wicri:regionArea></affiliation></author><author><name sortKey="Ter Kuile, Feiko" sort="Ter Kuile, Feiko" uniqKey="Ter Kuile F" first="Feiko" last="Ter Kuile">Feiko Ter Kuile</name><affiliation wicri:level="1"><nlm:aff id="aff011"><addr-line>Liverpool School of Tropical Medicine, Liverpool, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool School of Tropical Medicine, Liverpool</wicri:regionArea></affiliation></author><author><name sortKey="Woukeu, Arouna" sort="Woukeu, Arouna" uniqKey="Woukeu A" first="Arouna" last="Woukeu">Arouna Woukeu</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Milligan, Paul" sort="Milligan, Paul" uniqKey="Milligan P" first="Paul" last="Milligan">Paul Milligan</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Chandramohan, Daniel" sort="Chandramohan, Daniel" uniqKey="Chandramohan D" first="Daniel" last="Chandramohan">Daniel Chandramohan</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Greenwood, Brian" sort="Greenwood, Brian" uniqKey="Greenwood B" first="Brian" last="Greenwood">Brian Greenwood</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26258474</idno><idno type="pmc">4530893</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4530893</idno><idno type="RBID">PMC:4530893</idno><idno type="doi">10.1371/journal.pone.0132247</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000024</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000024</idno><idno type="wicri:Area/Pmc/Curation">000024</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000024</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy</title><author><name sortKey="Tagbor, Harry" sort="Tagbor, Harry" uniqKey="Tagbor H" first="Harry" last="Tagbor">Harry Tagbor</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi</wicri:regionArea></affiliation></author><author><name sortKey="Cairns, Matthew" sort="Cairns, Matthew" uniqKey="Cairns M" first="Matthew" last="Cairns">Matthew Cairns</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Bojang, Kalifa" sort="Bojang, Kalifa" uniqKey="Bojang K" first="Kalifa" last="Bojang">Kalifa Bojang</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></nlm:aff><country xml:lang="fr">Gambie</country><wicri:regionArea>Medical Research Council Unit, Fajara</wicri:regionArea></affiliation></author><author><name sortKey="Coulibaly, Sheick Oumar" sort="Coulibaly, Sheick Oumar" uniqKey="Coulibaly S" first="Sheick Oumar" last="Coulibaly">Sheick Oumar Coulibaly</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso</addr-line></nlm:aff><country xml:lang="fr">Burkina Faso</country><wicri:regionArea>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou</wicri:regionArea></affiliation></author><author><name sortKey="Kayentao, Kassoum" sort="Kayentao, Kassoum" uniqKey="Kayentao K" first="Kassoum" last="Kayentao">Kassoum Kayentao</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Williams, John" sort="Williams, John" uniqKey="Williams J" first="John" last="Williams">John Williams</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Abubakar, Ismaela" sort="Abubakar, Ismaela" uniqKey="Abubakar I" first="Ismaela" last="Abubakar">Ismaela Abubakar</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></nlm:aff><country xml:lang="fr">Gambie</country><wicri:regionArea>Medical Research Council Unit, Fajara</wicri:regionArea></affiliation></author><author><name sortKey="Akor, Francis" sort="Akor, Francis" uniqKey="Akor F" first="Francis" last="Akor">Francis Akor</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></nlm:aff><country xml:lang="fr">Gambie</country><wicri:regionArea>Medical Research Council Unit, Fajara</wicri:regionArea></affiliation></author><author><name sortKey="Mohammed, Khalifa" sort="Mohammed, Khalifa" uniqKey="Mohammed K" first="Khalifa" last="Mohammed">Khalifa Mohammed</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></nlm:aff><country xml:lang="fr">Gambie</country><wicri:regionArea>Medical Research Council Unit, Fajara</wicri:regionArea></affiliation></author><author><name sortKey="Bationo, Richard" sort="Bationo, Richard" uniqKey="Bationo R" first="Richard" last="Bationo">Richard Bationo</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso</addr-line></nlm:aff><country xml:lang="fr">Burkina Faso</country><wicri:regionArea>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou</wicri:regionArea></affiliation></author><author><name sortKey="Dabira, Edgar" sort="Dabira, Edgar" uniqKey="Dabira E" first="Edgar" last="Dabira">Edgar Dabira</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso</addr-line></nlm:aff><country xml:lang="fr">Burkina Faso</country><wicri:regionArea>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou</wicri:regionArea></affiliation></author><author><name sortKey="Soulama, Alamissa" sort="Soulama, Alamissa" uniqKey="Soulama A" first="Alamissa" last="Soulama">Alamissa Soulama</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso</addr-line></nlm:aff><country xml:lang="fr">Burkina Faso</country><wicri:regionArea>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou</wicri:regionArea></affiliation></author><author><name sortKey="Djimde, Moussa" sort="Djimde, Moussa" uniqKey="Djimde M" first="Moussa" last="Djimdé">Moussa Djimdé</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Guirou, Etienne" sort="Guirou, Etienne" uniqKey="Guirou E" first="Etienne" last="Guirou">Etienne Guirou</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Awine, Timothy" sort="Awine, Timothy" uniqKey="Awine T" first="Timothy" last="Awine">Timothy Awine</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Quaye, Stephen" sort="Quaye, Stephen" uniqKey="Quaye S" first="Stephen" last="Quaye">Stephen Quaye</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Njie, Fanta" sort="Njie, Fanta" uniqKey="Njie F" first="Fanta" last="Njie">Fanta Njie</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></nlm:aff><country xml:lang="fr">Gambie</country><wicri:regionArea>Medical Research Council Unit, Fajara</wicri:regionArea></affiliation></author><author><name sortKey="Ordi, Jaume" sort="Ordi, Jaume" uniqKey="Ordi J" first="Jaume" last="Ordi">Jaume Ordi</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>Barcelona Centre for International Health Research (CRESIB), Department of Pathology, Hospital Clinic-Universitat de Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Barcelona Centre for International Health Research (CRESIB), Department of Pathology, Hospital Clinic-Universitat de Barcelona, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Doumbo, Ogobara" sort="Doumbo, Ogobara" uniqKey="Doumbo O" first="Ogobara" last="Doumbo">Ogobara Doumbo</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></nlm:aff><country xml:lang="fr">Mali</country><wicri:regionArea>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako</wicri:regionArea></affiliation></author><author><name sortKey="Hodgson, Abraham" sort="Hodgson, Abraham" uniqKey="Hodgson A" first="Abraham" last="Hodgson">Abraham Hodgson</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Oduro, Abraham" sort="Oduro, Abraham" uniqKey="Oduro A" first="Abraham" last="Oduro">Abraham Oduro</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="Meshnick, Steven" sort="Meshnick, Steven" uniqKey="Meshnick S" first="Steven" last="Meshnick">Steven Meshnick</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC</wicri:regionArea></affiliation></author><author><name sortKey="Taylor, Steve" sort="Taylor, Steve" uniqKey="Taylor S" first="Steve" last="Taylor">Steve Taylor</name><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Duke University Medical Center, Durham, NC, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Duke University Medical Center, Durham, NC</wicri:regionArea></affiliation></author><author><name sortKey="Magnussen, Pascal" sort="Magnussen, Pascal" uniqKey="Magnussen P" first="Pascal" last="Magnussen">Pascal Magnussen</name><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>(Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen, Denmark</addr-line></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>(Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen</wicri:regionArea></affiliation></author><author><name sortKey="Ter Kuile, Feiko" sort="Ter Kuile, Feiko" uniqKey="Ter Kuile F" first="Feiko" last="Ter Kuile">Feiko Ter Kuile</name><affiliation wicri:level="1"><nlm:aff id="aff011"><addr-line>Liverpool School of Tropical Medicine, Liverpool, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool School of Tropical Medicine, Liverpool</wicri:regionArea></affiliation></author><author><name sortKey="Woukeu, Arouna" sort="Woukeu, Arouna" uniqKey="Woukeu A" first="Arouna" last="Woukeu">Arouna Woukeu</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Milligan, Paul" sort="Milligan, Paul" uniqKey="Milligan P" first="Paul" last="Milligan">Paul Milligan</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Chandramohan, Daniel" sort="Chandramohan, Daniel" uniqKey="Chandramohan D" first="Daniel" last="Chandramohan">Daniel Chandramohan</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Greenwood, Brian" sort="Greenwood, Brian" uniqKey="Greenwood B" first="Brian" last="Greenwood">Brian Greenwood</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene & Tropical Medicine, London</wicri:regionArea></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title><p>The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.</p></sec><sec id="sec002"><title>Methods and Findings</title><p>An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.</p></sec><sec id="sec003"><title>Conclusions</title><p>Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.</p></sec><sec id="sec004"><title>Trial Registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01084213">NCT01084213</ext-link></p><p>Pan African Clinical trials Registry <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/PACT201202000272122">PACT201202000272122</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Eisele, Tp" uniqKey="Eisele T">TP Eisele</name></author><author><name sortKey="Larsen, Da" uniqKey="Larsen D">DA Larsen</name></author><author><name sortKey="Anglewicz, Pa" uniqKey="Anglewicz P">PA Anglewicz</name></author><author><name sortKey="Keating, J" uniqKey="Keating J">J 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26258474</article-id><article-id pub-id-type="pmc">4530893</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0132247</article-id><article-id pub-id-type="publisher-id">PONE-D-15-10285</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy</article-title><alt-title alt-title-type="running-head">Screening and Treatment for Malaria in Pregnancy</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Tagbor</surname><given-names>Harry</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Cairns</surname><given-names>Matthew</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bojang</surname><given-names>Kalifa</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Coulibaly</surname><given-names>Sheick Oumar</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kayentao</surname><given-names>Kassoum</given-names></name><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Williams</surname><given-names>John</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Abubakar</surname><given-names>Ismaela</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Akor</surname><given-names>Francis</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Mohammed</surname><given-names>Khalifa</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bationo</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dabira</surname><given-names>Edgar</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Soulama</surname><given-names>Alamissa</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Djimdé</surname><given-names>Moussa</given-names></name><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Guirou</surname><given-names>Etienne</given-names></name><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Awine</surname><given-names>Timothy</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Quaye</surname><given-names>Stephen</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Njie</surname><given-names>Fanta</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ordi</surname><given-names>Jaume</given-names></name><xref ref-type="aff" rid="aff007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Doumbo</surname><given-names>Ogobara</given-names></name><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Hodgson</surname><given-names>Abraham</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Oduro</surname><given-names>Abraham</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Meshnick</surname><given-names>Steven</given-names></name><xref ref-type="aff" rid="aff008"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Taylor</surname><given-names>Steve</given-names></name><xref ref-type="aff" rid="aff009"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Magnussen</surname><given-names>Pascal</given-names></name><xref ref-type="aff" rid="aff010"><sup>10</sup></xref></contrib><contrib contrib-type="author"><name><surname>ter Kuile</surname><given-names>Feiko</given-names></name><xref ref-type="aff" rid="aff011"><sup>11</sup></xref></contrib><contrib contrib-type="author"><name><surname>Woukeu</surname><given-names>Arouna</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Milligan</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Chandramohan</surname><given-names>Daniel</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Greenwood</surname><given-names>Brian</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref rid="cor001" ref-type="corresp">*</xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></aff><aff id="aff002"><label>2</label><addr-line>School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana</addr-line></aff><aff id="aff003"><label>3</label><addr-line>Medical Research Council Unit, Fajara, The Gambia</addr-line></aff><aff id="aff004"><label>4</label><addr-line>Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso</addr-line></aff><aff id="aff005"><label>5</label><addr-line>Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali</addr-line></aff><aff id="aff006"><label>6</label><addr-line>Navrongo Health Research Centre, Navrongo, Ghana</addr-line></aff><aff id="aff007"><label>7</label><addr-line>Barcelona Centre for International Health Research (CRESIB), Department of Pathology, Hospital Clinic-Universitat de Barcelona, Barcelona, Spain</addr-line></aff><aff id="aff008"><label>8</label><addr-line>Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America</addr-line></aff><aff id="aff009"><label>9</label><addr-line>Duke University Medical Center, Durham, NC, United States of America</addr-line></aff><aff id="aff010"><label>10</label><addr-line>(Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen, Denmark</addr-line></aff><aff id="aff011"><label>11</label><addr-line>Liverpool School of Tropical Medicine, Liverpool, United Kingdom</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Gutman</surname><given-names>Julie</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>Centers for Disease Control and Prevention, UNITED STATES</addr-line></aff><author-notes><fn fn-type="conflict" id="coi001"><p><bold>Competing Interests: </bold>The authors have declared that no competing interests exist.</p></fn><fn fn-type="con" id="contrib001"><p>Conceived and designed the experiments: HT SC P. Magnussen FtK DC BG P. Milligan KK OD KB JW AH AO. Performed the experiments: HT SC ED RB AS MD KK EG IA FA KM SQ JW FN JO ST SM AW TA MC P. Milligan. Analyzed the data: MC HT FtK BG P. Milligan. Wrote the paper: HT SC P. Magnussen FtK DC BG P. Milligan KK OD KB JW AH AO ED RB AS MD EG IA FA KM SQ FN JO ST SM AW TA MC.</p></fn><corresp id="cor001">* E-mail: <email>brian.greenwood@lshtm.ac.uk</email></corresp></author-notes><pub-date pub-type="epub"><day>10</day><month>8</month><year>2015</year></pub-date><pub-date pub-type="collection"><year>2015</year></pub-date><volume>10</volume><issue>8</issue><elocation-id>e0132247</elocation-id><history><date date-type="received"><day>17</day><month>3</month><year>2015</year></date><date date-type="accepted"><day>10</day><month>6</month><year>2015</year></date></history><permissions><copyright-year>2015</copyright-year><copyright-holder>Tagbor et al</copyright-holder><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License</ext-link>, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="pone.0132247.pdf"></self-uri><abstract><sec id="sec001"><title>Background</title><p>The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.</p></sec><sec id="sec002"><title>Methods and Findings</title><p>An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.</p></sec><sec id="sec003"><title>Conclusions</title><p>Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.</p></sec><sec id="sec004"><title>Trial Registration</title><p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01084213">NCT01084213</ext-link></p><p>Pan African Clinical trials Registry <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/PACT201202000272122">PACT201202000272122</ext-link></p></sec></abstract><funding-group><funding-statement>The study was funded by the European Developing Country Clinical Trials Programme (grant number IP.2007.31080.003) and by the Malaria in Pregnancy Consortium which is funded through a grant from the Bill & Melinda Gates Foundation to the Liverpool School of Tropical Medicine. MC is supported by a fellowship jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</funding-statement></funding-group><counts><fig-count count="3"></fig-count><table-count count="4"></table-count><page-count count="17"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>Data are available from The London School of Hygiene & Tropical Medicine Data Repository at <ext-link ext-link-type="uri" xlink:href="http://datacompass.lshtm.ac.uk/4/">http://datacompass.lshtm.ac.uk/4/</ext-link>. The DOI for the data collection is <ext-link ext-link-type="uri" xlink:href="http://dx.doi.org/10.17037/DATA.2">http://dx.doi.org/10.17037/DATA.2</ext-link>.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>Data are available from The London School of Hygiene & Tropical Medicine Data Repository at <ext-link ext-link-type="uri" xlink:href="http://datacompass.lshtm.ac.uk/4/">http://datacompass.lshtm.ac.uk/4/</ext-link>. The DOI for the data collection is <ext-link ext-link-type="uri" xlink:href="http://dx.doi.org/10.17037/DATA.2">http://dx.doi.org/10.17037/DATA.2</ext-link>.</p></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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