Protective Efficacy and Safety of Three Antimalarial Regimens for the Prevention of Malaria in Young Ugandan Children: A Randomized Controlled Trial
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{"title"=>"Protective Efficacy and Safety of Three Antimalarial Regimens for the Prevention of Malaria in Young Ugandan Children: A Randomized Controlled Trial", "type"=>"journal", "authors"=>[{"first_name"=>"Victor", "last_name"=>"Bigira"}, {"first_name"=>"James", "last_name"=>"Kapisi"}, {"first_name"=>"Tamara D.", "last_name"=>"Clark"}, {"first_name"=>"Stephen", "last_name"=>"Kinara"}, {"first_name"=>"Florence", "last_name"=>"Mwangwa"}, {"first_name"=>"Mary K.", "last_name"=>"Muhindo"}, {"first_name"=>"Beth", "last_name"=>"Osterbauer"}, {"first_name"=>"Francesca T.", "last_name"=>"Aweeka"}, {"first_name"=>"Liusheng", "last_name"=>"Huang"}, {"first_name"=>"Jane", "last_name"=>"Achan"}, {"first_name"=>"Diane V.", "last_name"=>"Havlir"}, {"first_name"=>"Philip J.", "last_name"=>"Rosenthal"}, {"first_name"=>"Moses R.", "last_name"=>"Kamya"}, {"first_name"=>"Grant", "last_name"=>"Dorsey"}], "year"=>2014, "source"=>"PLoS Medicine", "identifiers"=>{"doi"=>"10.1371/journal.pmed.1001689", "pmid"=>"25093754", "issn"=>"1549-1676", "isbn"=>"0000000000000"}, "id"=>"8efbb0c5-6df1-30c5-8082-f176c47718b2", "abstract"=>"BACKGROUND: Chemoprevention offers a promising strategy for prevention of malaria in African children. However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs. To compare three available regimens, we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children.\\n\\nMETHODS AND FINDINGS: This study was conducted between June 28, 2010, and September 25, 2013. 400 infants were enrolled and 393 randomized at 6 mo of age to no chemoprevention, monthly sulfadoxine-pyrimethamine (SP), daily trimethoprim-sulfamethoxazole (TS), or monthly dihydroartemisinin-piperaquine (DP). Study drugs were administered at home without supervision. Piperaquine (PQ) levels were used as a measure of compliance in the DP arm. Participants were given insecticide-treated bednets, and caregivers were encouraged to bring their child to a study clinic whenever they were ill. Chemoprevention was stopped at 24 mo of age, and participants followed-up an additional year. Primary outcome was the incidence of malaria during the intervention period. During the intervention, the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk. Protective efficacy was 58% (95% CI, 45%-67%, p<0.001) for DP, 28% (95% CI, 7%-44%, p = 0.01) for TS, and 7% for SP (95% CI, -19% to 28%, p = 0.57). PQ levels were below the detection limit 52% of the time when malaria was diagnosed in the DP arm, suggesting non-adherence. There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped.\\n\\nCONCLUSIONS: For preventing malaria in children living in an area of high transmission intensity, monthly DP was the most efficacious and safe, although adherence may pose a problem. Monthly SP and daily TS may not be appropriate in areas with high transmission intensity and frequent resistance to antifolates.\\n\\nTRIAL REGISTRATION: www.ClinicalTrials.gov NCT00948896 Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/protective-efficacy-safety-three-antimalarial-regimens-prevention-malaria-young-ugandan-children-ran-3", "reader_count"=>58, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Researcher"=>9, "Student > Doctoral Student"=>4, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>5, "Other"=>4, "Student > Master"=>16, "Student > Bachelor"=>5, "Lecturer"=>3, "Lecturer > Senior Lecturer"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Researcher"=>9, "Student > Doctoral Student"=>4, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>5, "Other"=>4, "Student > Master"=>16, "Student > Bachelor"=>5, "Lecturer"=>3, "Lecturer > Senior Lecturer"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Agricultural and Biological Sciences"=>5, "Arts and Humanities"=>4, "Business, Management and Accounting"=>1, "Computer Science"=>1, "Economics, Econometrics and Finance"=>1, "Environmental Science"=>1, "Nursing and Health Professions"=>3, "Medicine and Dentistry"=>27, "Neuroscience"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>2, "Psychology"=>1, "Social Sciences"=>8, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>27}, "Social Sciences"=>{"Social Sciences"=>8}, "Psychology"=>{"Psychology"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}, "Arts and Humanities"=>{"Arts and Humanities"=>4}, "Neuroscience"=>{"Neuroscience"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>3}}, "reader_count_by_country"=>{"Burkina Faso"=>1, "Brazil"=>1, "United Kingdom"=>1, "Germany"=>1}, "group_count"=>2}

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  • {"files"=>["https://ndownloader.figshare.com/files/1624301"], "description"=>"a<p>Includes only those categories with at least five total events.</p><p>*<i>p</i><0.05 compared to control group;</p><p>**<i>p</i><0.01 compared to control group;</p><p>***<i>p</i><0.001 compared to control group.</p><p>N/A, not applicable; PYAR, person-years at risk.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Infectious diseases", "Parasitic diseases", "malaria"], "article_id"=>1129942, "categories"=>["Biological Sciences"], "users"=>["Victor Bigira", "James Kapisi", "Tamara D. Clark", "Stephen Kinara", "Florence Mwangwa", "Mary K. Muhindo", "Beth Osterbauer", "Francesca T. Aweeka", "Liusheng Huang", "Jane Achan", "Diane V. Havlir", "Philip J. Rosenthal", "Moses R. Kamya", "Grant Dorsey"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001689.t005", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparative_safety_outcomes_/1129942", "title"=>"Comparative safety outcomes.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-05 06:47:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/1624298"], "description"=>"<p>PYAR, person-years at risk.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Infectious diseases", "Parasitic diseases", "malaria", "stratified", "assigned"], "article_id"=>1129939, "categories"=>["Biological Sciences"], "users"=>["Victor Bigira", "James Kapisi", "Tamara D. Clark", "Stephen Kinara", "Florence Mwangwa", "Mary K. Muhindo", "Beth Osterbauer", "Francesca T. Aweeka", "Liusheng Huang", "Jane Achan", "Diane V. Havlir", "Philip J. Rosenthal", "Moses R. Kamya", "Grant Dorsey"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001689.g002", "stats"=>{"downloads"=>4, "page_views"=>20, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Incidence_of_malaria_over_age_stratified_by_assigned_study_arm_/1129939", "title"=>"Incidence of malaria over age, stratified by assigned study arm.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-05 06:47:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/1624314", "https://ndownloader.figshare.com/files/1624316", "https://ndownloader.figshare.com/files/1624317", "https://ndownloader.figshare.com/files/1624318", "https://ndownloader.figshare.com/files/1624319"], "description"=>"<div><p>Background</p><p>Chemoprevention offers a promising strategy for prevention of malaria in African children. However, the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs. To compare three available regimens, we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children.</p><p>Methods and Findings</p><p>This study was conducted between June 28, 2010, and September 25, 2013. 400 infants were enrolled and 393 randomized at 6 mo of age to no chemoprevention, monthly sulfadoxine-pyrimethamine (SP), daily trimethoprim-sulfamethoxazole (TS), or monthly dihydroartemisinin-piperaquine (DP). Study drugs were administered at home without supervision. Piperaquine (PQ) levels were used as a measure of compliance in the DP arm. Participants were given insecticide-treated bednets, and caregivers were encouraged to bring their child to a study clinic whenever they were ill. Chemoprevention was stopped at 24 mo of age, and participants followed-up an additional year. Primary outcome was the incidence of malaria during the intervention period. During the intervention, the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk. Protective efficacy was 58% (95% CI, 45%–67%, <i>p</i><0.001) for DP, 28% (95% CI, 7%–44%, <i>p</i> = 0.01) for TS, and 7% for SP (95% CI, −19% to 28%, <i>p</i> = 0.57). PQ levels were below the detection limit 52% of the time when malaria was diagnosed in the DP arm, suggesting non-adherence. There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the 1-y period after the intervention was stopped.</p><p>Conclusions</p><p>For preventing malaria in children living in an area of high transmission intensity, monthly DP was the most efficacious and safe, although adherence may pose a problem. Monthly SP and daily TS may not be appropriate in areas with high transmission intensity and frequent resistance to antifolates.</p><p>Trial registration</p><p><a href=\"http://www.ClinicalTrials.gov\" target=\"_blank\">www.ClinicalTrials.gov</a><a href=\"http://clinicaltrials.gov/ct2/show/NCT00948896\" target=\"_blank\">NCT00948896</a></p><p><i>Please see later in the article for the Editors' Summary</i></p></div>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Infectious diseases", "Parasitic diseases", "malaria", "efficacy", "antimalarial", "regimens", "ugandan", "randomized", "controlled"], "article_id"=>1129956, "categories"=>["Biological Sciences"], "users"=>["Victor Bigira", "James Kapisi", "Tamara D. Clark", "Stephen Kinara", "Florence Mwangwa", "Mary K. Muhindo", "Beth Osterbauer", "Francesca T. Aweeka", "Liusheng Huang", "Jane Achan", "Diane V. Havlir", "Philip J. Rosenthal", "Moses R. Kamya", "Grant Dorsey"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001689.s001", "https://dx.doi.org/10.1371/journal.pmed.1001689.s002", "https://dx.doi.org/10.1371/journal.pmed.1001689.s003", "https://dx.doi.org/10.1371/journal.pmed.1001689.s004", "https://dx.doi.org/10.1371/journal.pmed.1001689.s005"], "stats"=>{"downloads"=>30, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Protective_Efficacy_and_Safety_of_Three_Antimalarial_Regimens_for_the_Prevention_of_Malaria_in_Young_Ugandan_Children_A_Randomized_Controlled_Trial_/1129956", "title"=>"Protective Efficacy and Safety of Three Antimalarial Regimens for the Prevention of Malaria in Young Ugandan Children: A Randomized Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-08-05 06:47:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/1624297"], "description"=>"<p><sup>1</sup>Only data that accrued until the study participant was prematurely withdrawn from the study were included in the modified intention-to-treat analysis. <sup>2</sup>Complete data included in the modified intention-to-treat analysis.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Infectious diseases", "Parasitic diseases", "malaria"], "article_id"=>1129938, "categories"=>["Biological Sciences"], "users"=>["Victor Bigira", "James Kapisi", "Tamara D. Clark", "Stephen Kinara", "Florence Mwangwa", "Mary K. Muhindo", "Beth Osterbauer", "Francesca T. Aweeka", "Liusheng Huang", "Jane Achan", "Diane V. Havlir", "Philip J. Rosenthal", "Moses R. Kamya", "Grant Dorsey"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001689.g001", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_/1129938", "title"=>"Trial profile.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-05 06:47:30"}

PMC Usage Stats | Further Information

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Relative Metric

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