Artemisinin-Naphthoquine versus Artemether-Lumefantrine for Uncomplicated Malaria in Papua New Guinean Children: An Open-Label Randomized Trial
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{"title"=>"Artemisinin-Naphthoquine versus Artemether-Lumefantrine for Uncomplicated Malaria in Papua New Guinean Children: An Open-Label Randomized Trial", "type"=>"journal", "authors"=>[{"first_name"=>"Moses", "last_name"=>"Laman", "scopus_author_id"=>"35798443700"}, {"first_name"=>"Brioni R.", "last_name"=>"Moore", "scopus_author_id"=>"23028470000"}, {"first_name"=>"John M.", "last_name"=>"Benjamin", "scopus_author_id"=>"55195097300"}, {"first_name"=>"Gumul", "last_name"=>"Yadi", "scopus_author_id"=>"56711907500"}, {"first_name"=>"Cathy", "last_name"=>"Bona", "scopus_author_id"=>"37119835600"}, {"first_name"=>"Jonathan", "last_name"=>"Warrel", "scopus_author_id"=>"36483753400"}, {"first_name"=>"Johanna H.", "last_name"=>"Kattenberg", "scopus_author_id"=>"54417360300"}, {"first_name"=>"Tamarah", "last_name"=>"Koleala", "scopus_author_id"=>"56398435500"}, {"first_name"=>"Laurens", "last_name"=>"Manning", "scopus_author_id"=>"16444571700"}, {"first_name"=>"Bernadine", "last_name"=>"Kasian", "scopus_author_id"=>"56398419300"}, {"first_name"=>"Leanne J.", "last_name"=>"Robinson", "scopus_author_id"=>"55139326100"}, {"first_name"=>"Naomi", "last_name"=>"Sambale", "scopus_author_id"=>"56481642300"}, {"first_name"=>"Lina", "last_name"=>"Lorry", "scopus_author_id"=>"56481681500"}, {"first_name"=>"Stephan", "last_name"=>"Karl", "scopus_author_id"=>"24177167100"}, {"first_name"=>"Wendy A.", "last_name"=>"Davis", "scopus_author_id"=>"7402806940"}, {"first_name"=>"Anna", "last_name"=>"Rosanas-Urgell", "scopus_author_id"=>"23669349400"}, {"first_name"=>"Ivo", "last_name"=>"Mueller", "scopus_author_id"=>"7006910183"}, {"first_name"=>"Peter M.", "last_name"=>"Siba", "scopus_author_id"=>"12241224200"}, {"first_name"=>"Inoni", "last_name"=>"Betuela", "scopus_author_id"=>"6507748085"}, {"first_name"=>"Timothy M.E.", "last_name"=>"Davis", "scopus_author_id"=>"57005974500"}], "year"=>2014, "source"=>"PLoS Medicine", "identifiers"=>{"scopus"=>"2-s2.0-84920973136", "pui"=>"601416087", "pmid"=>"25549086", "issn"=>"15491676", "isbn"=>"1549-1277", "doi"=>"10.1371/journal.pmed.1001773", "sgr"=>"84920973136"}, "id"=>"b604dba6-f2df-398b-998c-b81311d7e979", "abstract"=>"BACKGROUND: Artemisinin combination therapies (ACTs) with broad efficacy are needed where multiple Plasmodium species are transmitted, especially in children, who bear the brunt of infection in endemic areas. In Papua New Guinea (PNG), artemether-lumefantrine is the first-line treatment for uncomplicated malaria, but it has limited efficacy against P. vivax. Artemisinin-naphthoquine should have greater activity in vivax malaria because the elimination of naphthoquine is slower than that of lumefantrine. In this study, the efficacy, tolerability, and safety of these ACTs were assessed in PNG children aged 0.5-5 y.\\n\\nMETHODS AND FINDINGS: An open-label, randomized, parallel-group trial of artemether-lumefantrine (six doses over 3 d) and artemisinin-naphthoquine (three daily doses) was conducted between 28 March 2011 and 22 April 2013. Parasitologic outcomes were assessed without knowledge of treatment allocation. Primary endpoints were the 42-d P. falciparum PCR-corrected adequate clinical and parasitologic response (ACPR) and the P. vivax PCR-uncorrected 42-d ACPR. Non-inferiority and superiority designs were used for falciparum and vivax malaria, respectively. Because the artemisinin-naphthoquine regimen involved three doses rather than the manufacturer-specified single dose, the first 188 children underwent detailed safety monitoring. Of 2,542 febrile children screened, 267 were randomized, and 186 with falciparum and 47 with vivax malaria completed the 42-d follow-up. Both ACTs were safe and well tolerated. P. falciparum ACPRs were 97.8% and 100.0% in artemether-lumefantrine and artemisinin-naphthoquine-treated patients, respectively (difference 2.2% [95% CI -3.0% to 8.4%] versus -5.0% non-inferiority margin, p = 0.24), and P. vivax ACPRs were 30.0% and 100.0%, respectively (difference 70.0% [95% CI 40.9%-87.2%], p<0.001). Limitations included the exclusion of 11% of randomized patients with sub-threshold parasitemias on confirmatory microscopy and direct observation of only morning artemether-lumefantrine dosing.\\n\\nCONCLUSIONS: Artemisinin-naphthoquine is non-inferior to artemether-lumefantrine in PNG children with falciparum malaria but has greater efficacy against vivax malaria, findings with implications in similar geo-epidemiologic settings within and beyond Oceania.\\n\\nTRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000913077. Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/artemisininnaphthoquine-versus-artemetherlumefantrine-uncomplicated-malaria-papua-new-guinean-childr", "reader_count"=>37, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Researcher"=>7, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>4, "Student > Master"=>5, "Other"=>5, "Student > Bachelor"=>3, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Researcher"=>7, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>4, "Student > Master"=>5, "Other"=>5, "Student > Bachelor"=>3, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Nursing and Health Professions"=>2, "Mathematics"=>1, "Medicine and Dentistry"=>19, "Agricultural and Biological Sciences"=>6, "Design"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>2, "Chemistry"=>1, "Psychology"=>1, "Immunology and Microbiology"=>1, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Design"=>{"Design"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>19}, "Chemistry"=>{"Chemistry"=>1}, "Psychology"=>{"Psychology"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}}, "reader_count_by_country"=>{"Burkina Faso"=>1, "Brazil"=>1, "United Kingdom"=>1, "Kenya"=>1}, "group_count"=>8}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/1857911"], "description"=>"<p>IQR, interquartile range.</p><p>Electrocardiographic QT<sub>c</sub> measurements by allocated treatment.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282016, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t004", "stats"=>{"downloads"=>4, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Electrocardiographic_QT_c_measurements_by_allocated_treatment_/1282016", "title"=>"Electrocardiographic QT<sub>c</sub> measurements by allocated treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
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  • {"files"=>["https://ndownloader.figshare.com/files/1857906"], "description"=>"<p>Data are median (interquartile range) or <i>n</i> (percent).</p><p>*Elevated serum creatinine (≥112 µmol/l), serum ALT (≥130 U/l), and total serum bilirubin (≥23.8 µmol/l) are defined as>3 times the upper limit of normal values in PNG children aged <5 y <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001773#pmed.1001773-Manning2\" target=\"_blank\">[26]</a>.</p><p>Biochemical measurements in the safety sub-study by allocated treatment.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282014, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t002", "stats"=>{"downloads"=>4, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Biochemical_measurements_in_the_safety_sub_study_by_allocated_treatment_/1282014", "title"=>"Biochemical measurements in the safety sub-study by allocated treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857903"], "description"=>"<p>Data are mean and standard deviation (vertical bars) for artemether-lumefantrine (▴, solid lines) and artemisinin-naphthoquine (•, dashed lines). **<i>p<</i>0.01 for between-treatment comparisons.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282011, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.g005", "stats"=>{"downloads"=>2, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Hemoglobin_concentrations_during_follow_up_after_treatment_for_P_falciparum_and_for_P_vivax_/1282011", "title"=>"Hemoglobin concentrations during follow-up after treatment for <i>P. falciparum</i> and for <i>P. vivax</i>.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857917"], "description"=>"<p>Modified intention-to-treat analysis of treatment response by treatment allocation utilizing a worst-case scenario (i.e., all instances of missing data during follow-up scored as treatment failure).</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282023, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t009", "stats"=>{"downloads"=>7, "page_views"=>24, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Modified_intention_to_treat_analysis_of_treatment_response_by_treatment_allocation_utilizing_a_worst_case_scenario_i_e_all_instances_of_missing_data_during_follow_up_scored_as_treatment_failure_/1282023", "title"=>"Modified intention-to-treat analysis of treatment response by treatment allocation utilizing a worst-case scenario (i.e., all instances of missing data during follow-up scored as treatment failure).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857918"], "description"=>"<p>Modified intention-to-treat analysis of treatment response by treatment allocation utilizing a best-case scenario (i.e., all instances of missing data during follow-up scored as parasite-negative).</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282024, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t010", "stats"=>{"downloads"=>3, "page_views"=>24, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Modified_intention_to_treat_analysis_of_treatment_response_by_treatment_allocation_utilizing_a_best_case_scenario_i_e_all_instances_of_missing_data_during_follow_up_scored_as_parasite_negative_/1282024", "title"=>"Modified intention-to-treat analysis of treatment response by treatment allocation utilizing a best-case scenario (i.e., all instances of missing data during follow-up scored as parasite-negative).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857913"], "description"=>"<p>Data are number/total (percentage) or mean (95% confidence interval).</p><p>Fever and parasite clearance times by <i>Plasmodium</i> species and allocated treatment.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282019, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t006", "stats"=>{"downloads"=>4, "page_views"=>23, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Fever_and_parasite_clearance_times_by_Plasmodium_species_and_allocated_treatment_/1282019", "title"=>"Fever and parasite clearance times by <i>Plasmodium</i> species and allocated treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857895"], "description"=>"<p>Data are for artemether-lumefantrine (solid lines) and artemisinin-naphthoquine (dashed lines). Numbers of children at risk at each time point are shown for artemether-lumefantrine (AL) and artemisinin-naphthoquine (AN). <i>p</i>-Values are for log-rank tests.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282004, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.g003", "stats"=>{"downloads"=>2, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_plots_showing_percentages_of_patients_positive_for_PCR_corrected_P_falciparum_and_for_PCR_uncorrected_P_vivax_after_treatment_/1282004", "title"=>"Kaplan-Meier plots showing percentages of patients positive for PCR-corrected <i>P. falciparum</i> and for PCR-uncorrected <i>P. vivax</i> after treatment.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857912"], "description"=>"<p>Data are percentage, mean ± standard deviation, median (interquartile range), or median [absolute range].</p><p>Baseline characteristics of patients classified by <i>Plasmodium</i> species and allocated treatment.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282018, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t005", "stats"=>{"downloads"=>3, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_of_patients_classified_by_Plasmodium_species_and_allocated_treatment_/1282018", "title"=>"Baseline characteristics of patients classified by <i>Plasmodium</i> species and allocated treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857892"], "description"=>"<p>Data are median and interquartile range (vertical bars) for artemether-lumefantrine (▴, solid lines) and artemisinin-naphthoquine (•, dashed lines). **<i>p<</i>0.01 for between-treatment comparisons.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282000, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.g002", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Electrocardiographic_QT_c_intervals_after_treatment_for_uncomplicated_malaria_/1282000", "title"=>"Electrocardiographic QT<sub>c</sub> intervals after treatment for uncomplicated malaria.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857904"], "description"=>"<p>IQR, interquartile range; SD, standard deviation.</p><p>Demographic, clinical, and laboratory parameters as part of safety monitoring.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282012, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t001", "stats"=>{"downloads"=>7, "page_views"=>21, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographic_clinical_and_laboratory_parameters_as_part_of_safety_monitoring_/1282012", "title"=>"Demographic, clinical, and laboratory parameters as part of safety monitoring.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857923", "https://ndownloader.figshare.com/files/1857924"], "description"=>"<div><p>Background</p><p>Artemisinin combination therapies (ACTs) with broad efficacy are needed where multiple <i>Plasmodium</i> species are transmitted, especially in children, who bear the brunt of infection in endemic areas. In Papua New Guinea (PNG), artemether-lumefantrine is the first-line treatment for uncomplicated malaria, but it has limited efficacy against <i>P. vivax</i>. Artemisinin-naphthoquine should have greater activity in vivax malaria because the elimination of naphthoquine is slower than that of lumefantrine. In this study, the efficacy, tolerability, and safety of these ACTs were assessed in PNG children aged 0.5–5 y.</p><p>Methods and Findings</p><p>An open-label, randomized, parallel-group trial of artemether-lumefantrine (six doses over 3 d) and artemisinin-naphthoquine (three daily doses) was conducted between 28 March 2011 and 22 April 2013. Parasitologic outcomes were assessed without knowledge of treatment allocation. Primary endpoints were the 42-d <i>P. falciparum</i> PCR-corrected adequate clinical and parasitologic response (ACPR) and the <i>P. vivax</i> PCR-uncorrected 42-d ACPR. Non-inferiority and superiority designs were used for falciparum and vivax malaria, respectively. Because the artemisinin-naphthoquine regimen involved three doses rather than the manufacturer-specified single dose, the first 188 children underwent detailed safety monitoring. Of 2,542 febrile children screened, 267 were randomized, and 186 with falciparum and 47 with vivax malaria completed the 42-d follow-up. Both ACTs were safe and well tolerated. <i>P. falciparum</i> ACPRs were 97.8% and 100.0% in artemether-lumefantrine and artemisinin-naphthoquine-treated patients, respectively (difference 2.2% [95% CI −3.0% to 8.4%] versus −5.0% non-inferiority margin, <i>p = </i>0.24), and <i>P. vivax</i> ACPRs were 30.0% and 100.0%, respectively (difference 70.0% [95% CI 40.9%–87.2%], <i>p<</i>0.001). Limitations included the exclusion of 11% of randomized patients with sub-threshold parasitemias on confirmatory microscopy and direct observation of only morning artemether-lumefantrine dosing.</p><p>Conclusions</p><p>Artemisinin-naphthoquine is non-inferior to artemether-lumefantrine in PNG children with falciparum malaria but has greater efficacy against vivax malaria, findings with implications in similar geo-epidemiologic settings within and beyond Oceania.</p><p>Trial registration</p><p> Australian New Zealand Clinical Trials Registry <a href=\"https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336153\" target=\"_blank\">ACTRN12610000913077</a></p><p><i>Please see later in the article for the Editors' Summary</i></p></div>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282029, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001773.s001", "https://dx.doi.org/10.1371/journal.pmed.1001773.s002"], "stats"=>{"downloads"=>15, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Artemisinin_Naphthoquine_versus_Artemether_Lumefantrine_for_Uncomplicated_Malaria_in_Papua_New_Guinean_Children_An_Open_Label_Randomized_Trial_/1282029", "title"=>"Artemisinin-Naphthoquine versus Artemether-Lumefantrine for Uncomplicated Malaria in Papua New Guinean Children: An Open-Label Randomized Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857900"], "description"=>"<p>Data are for artemether-lumefantrine (▴, solid lines) and artemisinin-naphthoquine (•, dashed lines). *<i>p<</i>0.05, **<i>p<</i>0.01 for between-treatment comparisons.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282007, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.g004", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Proportions_of_patients_with_gametocytes_during_follow_up_after_treatment_for_P_falciparum_and_for_P_vivax_/1282007", "title"=>"Proportions of patients with gametocytes during follow-up after treatment for <i>P. falciparum</i> and for <i>P. vivax</i>.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857915"], "description"=>"<p>Per-protocol secondary endpoint analysis of response in children with PCR-uncorrected <i>P. falciparum</i> reinfections or PCR-corrected <i>P. vivax</i> recrudescence by treatment allocation.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282021, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t008", "stats"=>{"downloads"=>7, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Per_protocol_secondary_endpoint_analysis_of_response_in_children_with_PCR_uncorrected_P_falciparum_reinfections_or_PCR_corrected_P_vivax_recrudescence_by_treatment_allocation_/1282021", "title"=>"Per-protocol secondary endpoint analysis of response in children with PCR-uncorrected <i>P. falciparum</i> reinfections or PCR-corrected <i>P. vivax</i> recrudescence by treatment allocation.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857914"], "description"=>"<p>Per-protocol analysis of treatment responses in children with falciparum (after PCR correction) or vivax (PCR-uncorrected) malaria.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282020, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t007", "stats"=>{"downloads"=>3, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Per_protocol_analysis_of_treatment_responses_in_children_with_falciparum_after_PCR_correction_or_vivax_PCR_uncorrected_malaria_/1282020", "title"=>"Per-protocol analysis of treatment responses in children with falciparum (after PCR correction) or vivax (PCR-uncorrected) malaria.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/1857907"], "description"=>"<p>Poisson regression with follow-up time as the exposure was used to derive incident rate ratios with artemether-lumefantrine as reference. Data on signs/symptoms from ten children were lost prior to database entry.</p><p>IRR, incident rate ratio.</p><p>Incidence rate of main reported or observed signs and symptoms during the first 7 d of follow-up in randomized children, expressed as reports per 100 observations.</p>", "links"=>[], "tags"=>["dose", "vivax malaria", "New Zealand Clinical Trials Registry ACTRN 12610000913077Please", "Papua New Guinean Children", "randomized", "ci", "efficacy", "28 March 2011", "falciparum", "acpr", "PNG children", "Papua New Guinea", "22 April 2013. Parasitologic outcomes"], "article_id"=>1282015, "categories"=>["Biological Sciences"], "users"=>["Moses Laman", "Brioni R. Moore", "John M. Benjamin", "Gumul Yadi", "Cathy Bona", "Jonathan Warrel", "Johanna H. Kattenberg", "Tamarah Koleala", "Laurens Manning", "Bernadine Kasian", "Leanne J. Robinson", "Naomi Sambale", "Lina Lorry", "Stephan Karl", "Wendy A. Davis", "Anna Rosanas-Urgell", "Ivo Mueller", "Peter M. Siba", "Inoni Betuela", "Timothy M. E. Davis"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001773.t003", "stats"=>{"downloads"=>7, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Incidence_rate_of_main_reported_or_observed_signs_and_symptoms_during_the_first_7_d_of_follow_up_in_randomized_children_expressed_as_reports_per_100_observations_/1282015", "title"=>"Incidence rate of main reported or observed signs and symptoms during the first 7 d of follow-up in randomized children, expressed as reports per 100 observations.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-30 03:20:55"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"13", "full-text"=>"9", "pdf"=>"10", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"6"}
  • {"unique-ip"=>"8", "full-text"=>"7", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"7"}
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  • {"unique-ip"=>"11", "full-text"=>"16", "pdf"=>"4", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"10"}
  • {"unique-ip"=>"11", "full-text"=>"11", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"11"}
  • {"unique-ip"=>"30", "full-text"=>"37", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"12"}
  • {"unique-ip"=>"26", "full-text"=>"16", "pdf"=>"6", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2017", "month"=>"1"}
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  • {"unique-ip"=>"9", "full-text"=>"11", "pdf"=>"4", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"4"}
  • {"unique-ip"=>"12", "full-text"=>"27", "pdf"=>"2", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"5"}
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  • {"unique-ip"=>"8", "full-text"=>"28", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"7"}
  • {"unique-ip"=>"17", "full-text"=>"18", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"8"}
  • {"unique-ip"=>"21", "full-text"=>"27", "pdf"=>"2", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"9"}
  • {"unique-ip"=>"13", "full-text"=>"12", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"10"}
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  • {"unique-ip"=>"7", "full-text"=>"6", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2017", "month"=>"12"}
  • {"unique-ip"=>"15", "full-text"=>"14", "pdf"=>"1", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"1"}
  • {"unique-ip"=>"15", "full-text"=>"20", "pdf"=>"2", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"3"}
  • {"unique-ip"=>"7", "full-text"=>"7", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"1"}
  • {"unique-ip"=>"14", "full-text"=>"18", "pdf"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"4"}
  • {"unique-ip"=>"15", "full-text"=>"23", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"5"}
  • {"unique-ip"=>"11", "full-text"=>"11", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"6"}
  • {"unique-ip"=>"7", "full-text"=>"6", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2018", "month"=>"7"}
  • {"unique-ip"=>"7", "full-text"=>"10", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"8"}
  • {"unique-ip"=>"7", "full-text"=>"6", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"9"}
  • {"unique-ip"=>"12", "full-text"=>"8", "pdf"=>"5", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"10"}
  • {"unique-ip"=>"10", "full-text"=>"9", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2018", "month"=>"11"}
  • {"unique-ip"=>"13", "full-text"=>"16", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"12"}
  • {"unique-ip"=>"2", "full-text"=>"2", "pdf"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"2"}
  • {"unique-ip"=>"10", "full-text"=>"8", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"2", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"3"}
  • {"unique-ip"=>"19", "full-text"=>"19", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"2", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"4"}
  • {"unique-ip"=>"11", "full-text"=>"10", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"5"}

Relative Metric

{"start_date"=>"2014-01-01T00:00:00Z", "end_date"=>"2014-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences", "average_usage"=>[291]}, {"subject_area"=>"/Biology and life sciences/Biochemistry", "average_usage"=>[282]}, {"subject_area"=>"/Biology and life sciences/Parasitology", "average_usage"=>[398, 644]}, {"subject_area"=>"/Medicine and health sciences", "average_usage"=>[285]}, {"subject_area"=>"/Medicine and health sciences/Parasitic diseases", "average_usage"=>[418, 848]}, {"subject_area"=>"/People and places", "average_usage"=>[302]}]}
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