Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Negative Women: A Multicentre Randomized Controlled Trial
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{"title"=>"Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Negative Women: A Multicentre Randomized Controlled Trial", "type"=>"journal", "authors"=>[{"first_name"=>"Raquel", "last_name"=>"González", "scopus_author_id"=>"55832485400"}, {"first_name"=>"Ghyslain", "last_name"=>"Mombo-Ngoma", "scopus_author_id"=>"22954202900"}, {"first_name"=>"Smaïla", "last_name"=>"Ouédraogo", "scopus_author_id"=>"6701513817"}, {"first_name"=>"Mwaka A.", "last_name"=>"Kakolwa", "scopus_author_id"=>"56384480500"}, {"first_name"=>"Salim", "last_name"=>"Abdulla", "scopus_author_id"=>"7003814084"}, {"first_name"=>"Manfred", "last_name"=>"Accrombessi", "scopus_author_id"=>"55353650500"}, {"first_name"=>"John J.", "last_name"=>"Aponte", "scopus_author_id"=>"35594206200"}, {"first_name"=>"Daisy", "last_name"=>"Akerey-Diop", "scopus_author_id"=>"55383100900"}, {"first_name"=>"Arti", "last_name"=>"Basra", "scopus_author_id"=>"38960894900"}, {"first_name"=>"Valérie", "last_name"=>"Briand", "scopus_author_id"=>"15022008000"}, {"first_name"=>"Meskure", "last_name"=>"Capan", "scopus_author_id"=>"35084864800"}, {"first_name"=>"Michel", "last_name"=>"Cot", "scopus_author_id"=>"7006762308"}, {"first_name"=>"Abdunoor M.", "last_name"=>"Kabanywanyi", "scopus_author_id"=>"23473492400"}, {"first_name"=>"Christian", "last_name"=>"Kleine", "scopus_author_id"=>"55086570000"}, {"first_name"=>"Peter G.", "last_name"=>"Kremsner", "scopus_author_id"=>"35459833700"}, {"first_name"=>"Eusebio", "last_name"=>"Macete", "scopus_author_id"=>"7801401361"}, {"first_name"=>"Jean Rodolphe", "last_name"=>"Mackanga", "scopus_author_id"=>"55062286300"}, {"first_name"=>"Achille", "last_name"=>"Massougbodgi", "scopus_author_id"=>"56384490300"}, {"first_name"=>"Alfredo", "last_name"=>"Mayor", "scopus_author_id"=>"7004476230"}, {"first_name"=>"Arsenio", "last_name"=>"Nhacolo", "scopus_author_id"=>"15751824800"}, {"first_name"=>"Golbahar", "last_name"=>"Pahlavan", "scopus_author_id"=>"57193204426"}, {"first_name"=>"Michael", "last_name"=>"Ramharter", "scopus_author_id"=>"6601932667"}, {"first_name"=>"María", "last_name"=>"Rupérez", "scopus_author_id"=>"56057068500"}, {"first_name"=>"Esperança", "last_name"=>"Sevene", "scopus_author_id"=>"23981211300"}, {"first_name"=>"Anifa", "last_name"=>"Vala", "scopus_author_id"=>"56057478200"}, {"first_name"=>"Rella", "last_name"=>"Zoleko-Manego", "scopus_author_id"=>"56384492500"}, {"first_name"=>"Clara", "last_name"=>"Menéndez", "scopus_author_id"=>"55942254700"}], "year"=>2014, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491676", "scopus"=>"2-s2.0-84907951454", "pui"=>"600193986", "doi"=>"10.1371/journal.pmed.1001733", "isbn"=>"1549-1277", "sgr"=>"84907951454", "pmid"=>"25247709"}, "id"=>"cf10ec0b-2a85-3760-bd54-0b8376b2c977", "abstract"=>"BACKGROUND Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women. METHODS AND FINDINGS A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1) SP, (2) single dose MQ (15 mg/kg), and (3) split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome) between groups (360/2,778 [13.0%]) for MQ group and 177/1,398 (12.7%) for SP group; risk ratio [RR], 1.02 (95% CI 0.86-1.22; p=0.80 in the ITT analysis). Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51-0.96]; p=0.03) and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85-0.99]; p=0.03), and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52-0.88]; p=0.004) and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78-0.95]; p=0.003). There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported related adverse events were dizziness (ranging from 33.9% to 35.5% after dose 1; and 16.0% to 20.8% after dose 2) and vomiting (30.2% to 31.7%, after dose 1 and 15.3% to 17.4% after dose 2) with similar proportions in the full and split MQ arms. The open-label design is a limitation of the study that affects mainly the safety assessment. CONCLUSIONS Women taking MQ IPTp (15 mg/kg) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp. MQ recipients had less clinical malaria than SP recipients, and the pregnancy outcomes and safety profile were similar. MQ had poorer tolerability even when splitting the dose over two days. These results do not support a change in the current IPTp policy. TRIAL REGISTRATION ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001429343 Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/intermittent-preventive-treatment-malaria-pregnancy-mefloquine-hivnegative-women-multicentre-randomi-9", "reader_count"=>30, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>1, "Librarian"=>2, "Student > Doctoral Student"=>1, "Researcher"=>2, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>9, "Student > Bachelor"=>2, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>1, "Librarian"=>2, "Student > Doctoral Student"=>1, "Researcher"=>2, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>9, "Student > Bachelor"=>2, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_subject_area"=>{"Nursing and Health Professions"=>5, "Agricultural and Biological Sciences"=>4, "Medicine and Dentistry"=>14, "Philosophy"=>1, "Business, Management and Accounting"=>1, "Psychology"=>2, "Social Sciences"=>2, "Computer Science"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Social Sciences"=>{"Social Sciences"=>2}, "Psychology"=>{"Psychology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>5}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"Tanzania"=>1}, "group_count"=>1}

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  • {"files"=>["https://ndownloader.figshare.com/files/1686771"], "description"=>"<p>Time to first episode of clinical malaria. ITT cohort. Kaplan Meier graph.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178784, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.g003", "stats"=>{"downloads"=>5, "page_views"=>85, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Time_to_first_episode_of_clinical_malaria_ITT_cohort_Kaplan_Meier_graph_/1178784", "title"=>"Time to first episode of clinical malaria. ITT cohort. Kaplan Meier graph.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686763"], "description"=>"<p>Newborn weights not captured at birth but within the first week of life were estimated using a linear regression model.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178779, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.g002", "stats"=>{"downloads"=>0, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Birth_weight_distribution_by_study_country_and_IPTp_group_/1178779", "title"=>"Birth weight distribution by study country and IPTp group.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686782"], "description"=>"a<p>Arithmetic difference.</p>b<p>Proportional difference; ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]).</p>c<p>ATP analysis adjusted only by country.</p><p>OM, observed microscopy.</p><p>Malaria related outcomes at delivery.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178796, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t003", "stats"=>{"downloads"=>2, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Malaria_related_outcomes_at_delivery_/1178796", "title"=>"Malaria related outcomes at delivery.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686779"], "description"=>"<p>ITT cohort.</p>a<p><i>n</i> (column percentage).</p>b<p>Arithmetic mean (SD) [<i>n</i>].</p>c<p>Median (IQR) [<i>n</i>].</p><p>MUAC, middle upper arm circumference.</p><p>Baseline characteristics.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178793, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t001", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_/1178793", "title"=>"Baseline characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686777"], "description"=>"<p>Reported medication-related adverse events.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178791, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.g004", "stats"=>{"downloads"=>0, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reported_medication_related_adverse_events_/1178791", "title"=>"Reported medication-related adverse events.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686791"], "description"=>"<p>Most frequent medication related adverse events (safety cohort).</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178805, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t007", "stats"=>{"downloads"=>4, "page_views"=>23, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Most_frequent_medication_related_adverse_events_safety_cohort_/1178805", "title"=>"Most frequent medication related adverse events (safety cohort).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686753"], "description"=>"<p>Trial profile (modified ITT cohort).</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178769, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.g001", "stats"=>{"downloads"=>0, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_modified_ITT_cohort_/1178769", "title"=>"Trial profile (modified ITT cohort).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686817", "https://ndownloader.figshare.com/files/1686818", "https://ndownloader.figshare.com/files/1686819", "https://ndownloader.figshare.com/files/1686820", "https://ndownloader.figshare.com/files/1686821", "https://ndownloader.figshare.com/files/1686822", "https://ndownloader.figshare.com/files/1686823", "https://ndownloader.figshare.com/files/1686824", "https://ndownloader.figshare.com/files/1686825", "https://ndownloader.figshare.com/files/1686826", "https://ndownloader.figshare.com/files/1686827", "https://ndownloader.figshare.com/files/1686828", "https://ndownloader.figshare.com/files/1686829"], "description"=>"<div><p>Background</p><p>Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.</p><p>Methods and Findings</p><p>A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1) SP, (2) single dose MQ (15 mg/kg), and (3) split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome) between groups (360/2,778 [13.0%]) for MQ group and 177/1,398 (12.7%) for SP group; risk ratio [RR], 1.02 (95% CI 0.86–1.22; <i>p</i> = 0.80 in the ITT analysis). Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51–0.96]; <i>p</i> = 0.03) and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85–0.99]; <i>p</i> = 0.03), and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52–0.88]; <i>p</i> = 0.004) and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78–0.95]; <i>p</i> = 0.003). There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported related adverse events were dizziness (ranging from 33.9% to 35.5% after dose 1; and 16.0% to 20.8% after dose 2) and vomiting (30.2% to 31.7%, after dose 1 and 15.3% to 17.4% after dose 2) with similar proportions in the full and split MQ arms. The open-label design is a limitation of the study that affects mainly the safety assessment.</p><p>Conclusions</p><p>Women taking MQ IPTp (15 mg/kg) in the context of long lasting insecticide treated nets had similar prevalence rates of low birth weight as those taking SP IPTp. MQ recipients had less clinical malaria than SP recipients, and the pregnancy outcomes and safety profile were similar. MQ had poorer tolerability even when splitting the dose over two days. These results do not support a change in the current IPTp policy.</p><p>Trial registration</p><p><a href=\"http://clinicaltrials.gov/show/NCT00811421\" target=\"_blank\">ClinicalTrials.gov NCT 00811421</a>; <a href=\"http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR2010020001429343\" target=\"_blank\">Pan African Clinical Trials Registry PACTR 2010020001429343</a></p><p><i>Please see later in the article for the Editors' Summary</i></p></div>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178830, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001733.s001", "https://dx.doi.org/10.1371/journal.pmed.1001733.s002", "https://dx.doi.org/10.1371/journal.pmed.1001733.s003", "https://dx.doi.org/10.1371/journal.pmed.1001733.s004", "https://dx.doi.org/10.1371/journal.pmed.1001733.s005", "https://dx.doi.org/10.1371/journal.pmed.1001733.s006", "https://dx.doi.org/10.1371/journal.pmed.1001733.s007", "https://dx.doi.org/10.1371/journal.pmed.1001733.s008", "https://dx.doi.org/10.1371/journal.pmed.1001733.s009", "https://dx.doi.org/10.1371/journal.pmed.1001733.s010", "https://dx.doi.org/10.1371/journal.pmed.1001733.s011", "https://dx.doi.org/10.1371/journal.pmed.1001733.s012", "https://dx.doi.org/10.1371/journal.pmed.1001733.s013"], "stats"=>{"downloads"=>47, "page_views"=>40, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Intermittent_Preventive_Treatment_of_Malaria_in_Pregnancy_with_Mefloquine_in_HIV_Negative_Women_A_Multicentre_Randomized_Controlled_Trial_/1178830", "title"=>"Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Negative Women: A Multicentre Randomized Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686786"], "description"=>"a<p>Episodes person/year; ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]); ITT analysis adjusted by country.</p><p>Incidence of clinical malaria, outpatients visits, and hospital admissions.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178798, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t004", "stats"=>{"downloads"=>1, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Incidence_of_clinical_malaria_outpatients_visits_and_hospital_admissions_/1178798", "title"=>"Incidence of clinical malaria, outpatients visits, and hospital admissions.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686781"], "description"=>"<p>ITT analysis adjusted by country. Interaction country×treatment: χ<sup>2</sup>: 1.22 with 3 degrees of freedom <i>p</i> = 0.766.</p><p>ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]). Interaction country×treatment: χ<sup>2</sup>: 0.31 with 3 degrees of freedom <i>p</i> = 0.959.</p><p>Low birth weight (<2,500 g at birth) rates by treatment group and country.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178795, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t002", "stats"=>{"downloads"=>2, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Low_birth_weight_lt_2_500_g_at_birth_rates_by_treatment_group_and_country_/1178795", "title"=>"Low birth weight (<2,500 g at birth) rates by treatment group and country.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686795"], "description"=>"<p>List of possibly/probably related SAEs.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178809, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t010", "stats"=>{"downloads"=>3, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_List_of_possibly_probably_related_SAEs_/1178809", "title"=>"List of possibly/probably related SAEs.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
  • {"files"=>["https://ndownloader.figshare.com/files/1686793"], "description"=>"<p>N, number of participants with at least one event.</p><p>Adverse events by system organ class and treatment group.</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178807, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t009", "stats"=>{"downloads"=>7, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Adverse_events_by_system_organ_class_and_treatment_group_/1178807", "title"=>"Adverse events by system organ class and treatment group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
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  • {"files"=>["https://ndownloader.figshare.com/files/1686790"], "description"=>"<p>Immediate tolerability (safety cohort).</p>", "links"=>[], "tags"=>["dose", "Multicentre Randomized Controlled Trial BackgroundIntermittent", "rr", "pregnancy outcomes", "PYAR", "birth weight prevalence", "MQ group", "ipt", "iptp", "SP parasite resistance", "Clinical Trials Registry PACTR 2010020001429343", "split MQ arms", "SP group", "ci", "itt", "safety profile", "nct"], "article_id"=>1178803, "categories"=>["Biological Sciences"], "users"=>["Raquel González", "Ghyslain Mombo-Ngoma", "Smaila Ouédraogo", "Mwaka A. Kakolwa", "Salim Abdulla", "Manfred Accrombessi", "John J. Aponte", "Daisy Akerey-Diop", "Arti Basra", "Valérie Briand", "Meskure Capan", "Michel Cot", "Abdunoor M. Kabanywanyi", "Christian Kleine", "Peter G. Kremsner", "Eusébio Macete", "Jean-Rodolphe Mackanga", "Achille Massougbodgi", "Alfredo Mayor", "Arsenio Nhacolo", "Golbahar Pahlavan", "Michael Ramharter", "Maria Rupérez", "Esperança Sevene", "Anifa Valá", "Rella Zoleko-Manego", "Clara Menendez"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001733.t006", "stats"=>{"downloads"=>4, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Immediate_tolerability_safety_cohort_/1178803", "title"=>"Immediate tolerability (safety cohort).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-09-23 03:11:13"}
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PMC Usage Stats | Further Information

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Relative Metric

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