A Head-to-Head Comparison of Four Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children: A Randomized Trial
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{"title"=>"A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in african children: A randomized trial", "type"=>"journal", "authors"=>[{"last_name"=>"The Four Artemisinin-Based Combinations Study group", "scopus_author_id"=>"55989989700"}], "year"=>2011, "source"=>"PLoS Medicine", "identifiers"=>{"pui"=>"363018752", "isbn"=>"2009010000", "issn"=>"15491277", "doi"=>"10.1371/journal.pmed.1001119", "scopus"=>"2-s2.0-82555195187", "pmid"=>"22087077", "sgr"=>"82555195187"}, "id"=>"1e89fc92-743b-39ab-b244-7e7dcfc688e1", "abstract"=>"BACKGROUND: Artemisinin-based combination therapies (ACTs) are the mainstay for the management of uncomplicated malaria cases. However, up-to-date data able to assist sub-Saharan African countries formulating appropriate antimalarial drug policies are scarce.\\n\\nMETHODS AND FINDINGS: Between 9 July 2007 and 19 June 2009, a randomized, non-inferiority (10% difference threshold in efficacy at day 28) clinical trial was carried out at 12 sites in seven sub-Saharan African countries. Each site compared three of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), or chlorproguanil-dapsone-artesunate (CD+A). Overall, 4,116 children 6-59 mo old with uncomplicated Plasmodium falciparum malaria were treated (1,226 with AL, 1,002 with ASAQ, 413 with CD+A, and 1,475 with DHAPQ), actively followed up until day 28, and then passively followed up for the next 6 mo. At day 28, for the PCR-adjusted efficacy, non-inferiority was established for three pair-wise comparisons: DHAPQ (97.3%) versus AL (95.5%) (odds ratio [OR]: 0.59, 95% CI: 0.37-0.94); DHAPQ (97.6%) versus ASAQ (96.8%) (OR: 0.74, 95% CI: 0.41-1.34), and ASAQ (97.1%) versus AL (94.4%) (OR: 0.50, 95% CI: 0.28-0.92). For the PCR-unadjusted efficacy, AL was significantly less efficacious than DHAPQ (72.7% versus 89.5%) (OR: 0.27, 95% CI: 0.21-0.34) and ASAQ (66.2% versus 80.4%) (OR: 0.40, 95% CI: 0.30-0.53), while DHAPQ (92.2%) had higher efficacy than ASAQ (80.8%) but non-inferiority could not be excluded (OR: 0.35, 95% CI: 0.26-0.48). CD+A was significantly less efficacious than the other three treatments. Day 63 results were similar to those observed at day 28.\\n\\nCONCLUSIONS: This large head-to-head comparison of most currently available ACTs in sub-Saharan Africa showed that AL, ASAQ, and DHAPQ had excellent efficacy, up to day 63 post-treatment. The risk of recurrent infections was significantly lower for DHAPQ, followed by ASAQ and then AL, supporting the recent recommendation of considering DHAPQ as a valid option for the treatment of uncomplicated P. falciparum malaria.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00393679; Pan African Clinical Trials Registry PACTR2009010000911750", "link"=>"http://www.mendeley.com/research/headtohead-comparison-four-artemisininbased-combinations-treating-uncomplicated-malaria-african-chil-1", "reader_count"=>10, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Student > Doctoral Student"=>3, "Researcher"=>1, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Student > Bachelor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Student > Doctoral Student"=>3, "Researcher"=>1, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Student > Bachelor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Agricultural and Biological Sciences"=>1, "Medicine and Dentistry"=>3, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Business, Management and Accounting"=>1, "Psychology"=>1, "Computer Science"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>3}, "Psychology"=>{"Psychology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "group_count"=>2}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/362193", "https://ndownloader.figshare.com/files/362361", "https://ndownloader.figshare.com/files/362420", "https://ndownloader.figshare.com/files/362553", "https://ndownloader.figshare.com/files/362696"], "description"=>"<div><h3>Background</h3><p>Artemisinin-based combination therapies (ACTs) are the mainstay for the management of uncomplicated malaria cases. However, up-to-date data able to assist sub-Saharan African countries formulating appropriate antimalarial drug policies are scarce.</p> <h3>Methods and Findings</h3><p>Between 9 July 2007 and 19 June 2009, a randomized, non-inferiority (10% difference threshold in efficacy at day 28) clinical trial was carried out at 12 sites in seven sub-Saharan African countries. Each site compared three of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), or chlorproguanil-dapsone-artesunate (CD+A). Overall, 4,116 children 6–59 mo old with uncomplicated <em>Plasmodium falciparum</em> malaria were treated (1,226 with AL, 1,002 with ASAQ, 413 with CD+A, and 1,475 with DHAPQ), actively followed up until day 28, and then passively followed up for the next 6 mo. At day 28, for the PCR-adjusted efficacy, non-inferiority was established for three pair-wise comparisons: DHAPQ (97.3%) versus AL (95.5%) (odds ratio [OR]: 0.59, 95% CI: 0.37–0.94); DHAPQ (97.6%) versus ASAQ (96.8%) (OR: 0.74, 95% CI: 0.41–1.34), and ASAQ (97.1%) versus AL (94.4%) (OR: 0.50, 95% CI: 0.28–0.92). For the PCR-unadjusted efficacy, AL was significantly less efficacious than DHAPQ (72.7% versus 89.5%) (OR: 0.27, 95% CI: 0.21–0.34) and ASAQ (66.2% versus 80.4%) (OR: 0.40, 95% CI: 0.30–0.53), while DHAPQ (92.2%) had higher efficacy than ASAQ (80.8%) but non-inferiority could not be excluded (OR: 0.35, 95% CI: 0.26–0.48). CD+A was significantly less efficacious than the other three treatments. Day 63 results were similar to those observed at day 28.</p> <h3>Conclusions</h3><p>This large head-to-head comparison of most currently available ACTs in sub-Saharan Africa showed that AL, ASAQ, and DHAPQ had excellent efficacy, up to day 63 post-treatment. The risk of recurrent infections was significantly lower for DHAPQ, followed by ASAQ and then AL, supporting the recent recommendation of considering DHAPQ as a valid option for the treatment of uncomplicated <em>P. falciparum</em> malaria.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://clinicaltrial.gov/ct2/show/NCT00393679\">NCT00393679</a>; Pan African Clinical Trials Registry <a href=\"http://apps.who.int/trialsearch/Trial.aspx?TrialID=PACTR2009010000911750\">PACTR2009010000911750</a></p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["head-to-head", "artemisinin-based", "combinations", "treating", "uncomplicated", "malaria", "african", "randomized"], "article_id"=>131600, "categories"=>["Cancer"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.s001", "https://dx.doi.org/10.1371/journal.pmed.1001119.s002", "https://dx.doi.org/10.1371/journal.pmed.1001119.s003", "https://dx.doi.org/10.1371/journal.pmed.1001119.s004", "https://dx.doi.org/10.1371/journal.pmed.1001119.s005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Head_to_Head_Comparison_of_Four_Artemisinin_Based_Combinations_for_Treating_Uncomplicated_Malaria_in_African_Children_A_Randomized_Trial/131600", "title"=>"A Head-to-Head Comparison of Four Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children: A Randomized Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-11-08 00:26:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/714855"], "description"=>"<p>Adj TF, adjusted treatment failure; Unadj TF, unadjusted treatment failure.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>385226, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_up_to_day_28_/385226", "title"=>"Trial profile up to day 28.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:27:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/714969"], "description"=>"<p>ITT population; data pooled over all sites.</p>", "links"=>[], "tags"=>["patients", "was", "failure-free"], "article_id"=>385340, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Proportion_of_patients_whose_treatment_was_failure_free_by_day_of_follow_up_/385340", "title"=>"Proportion of patients whose treatment was failure-free by day of follow-up.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:29:00"}
  • {"files"=>["https://ndownloader.figshare.com/files/715032"], "description"=>"<p>OR (circles), 95% CI (horizontal bars), and non-inferiority limit (vertical bars) for each pair-wise analysis for PCR-unadjusted (left panel) and -adjusted (right panel) ACPR at days 28 (filled circles) and 63 (open circles) (ITT population). An OR and 95% CI<1 indicate a significantly higher efficacy of the second versus the first treatment of the pair-wise comparison. The non-inferiority limits (day 28 only) correspond to a 10% difference in efficacy, recalculated to an OR scale. Non-inferiority is established if the 95% CI lies completely above the non-inferiority limit.</p>", "links"=>[], "tags"=>["pair-wise", "comparisons", "28"], "article_id"=>385397, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Six_pair_wise_comparisons_at_day_28_and_day_63_/385397", "title"=>"Six pair-wise comparisons at day 28 and day 63.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:29:57"}
  • {"files"=>["https://ndownloader.figshare.com/files/715140"], "description"=>"<p>Risk difference and 95% CI for three pair-wise analyses by site for PCR-unadjusted (left panel) and -adjusted (right panel) ACPR at days 28 (filled circles) and 63 (open circles) (ITT population) (A) ASAQ versus DHAPQ; (B) AL versus ASAQ; (C) AL versus DHAPQ. BF, Burkina Faso; GA, Gabon; MZ, Mozambique; NG, Nigeria; RW, Rwanda; UG, Uganda; ZM, Zimbabwe.</p>", "links"=>[], "tags"=>["efficacy", "pair-wise"], "article_id"=>385503, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Treatment_efficacy_by_pair_wise_comparison_and_by_site_/385503", "title"=>"Treatment efficacy by pair-wise comparison and by site.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:31:43"}
  • {"files"=>["https://ndownloader.figshare.com/files/715271"], "description"=>"<p>(A) All patients regardless of gametocytemia at enrollment; (B) patients with gametocytes at enrollment excluded.</p>", "links"=>[], "tags"=>["prevalence"], "article_id"=>385643, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Gametocyte_prevalence_by_treatment_and_day_of_follow_up_/385643", "title"=>"Gametocyte prevalence by treatment and day of follow-up.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:34:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/715328"], "description"=>"<p>Hematological recovery determined by Hb changes compared to day 0. The boxplots contain the following information: median (bold line), first and third quartile (box), whiskers extending to 1.5× interquartile range, and all more extreme values.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>385697, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.g006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Hematological_recovery_by_treatment_and_day_of_follow_up_/385697", "title"=>"Hematological recovery by treatment and day of follow-up.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-08 01:34:57"}
  • {"files"=>["https://ndownloader.figshare.com/files/715385"], "description"=>"<p>Entomological inoculation rate is infective bites/person/year.</p>", "links"=>[], "tags"=>["tested"], "article_id"=>385752, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_treatment_to_be_tested_by_country_/385752", "title"=>"Study treatment to be tested by country.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:35:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/715400"], "description"=>"<p>ITT population; results pooled from all sites.</p><p>ETF, early treatment failure; LTF, late treatment failure (includes late parasitological and clinical failures; after day 28, only late clinical failures were detected).</p>", "links"=>[], "tags"=>["outcomes"], "article_id"=>385768, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Treatment_outcomes_by_treatment_/385768", "title"=>"Treatment outcomes by treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:36:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/715416"], "description"=>"<p>ALAT, alanine aminotransferase; IQR, interquartile range; SD, standard deviation.</p>", "links"=>[], "tags"=>["characteristics"], "article_id"=>385794, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_ITT_population_/385794", "title"=>"Baseline characteristics (ITT population).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:36:34"}
  • {"files"=>["https://ndownloader.figshare.com/files/715457"], "description"=>"<p>Values are <i>n</i> (percent).</p>a<p>AEs and related AEs recorded in, respectively, at least 10% and 5% of patients in any treatment group.</p>b<p>A related SAE is a SAE that the investigator classified as possibly, probably, or definitely related to the study drug.</p>", "links"=>[], "tags"=>["adverse", "events", "28", "patients", "having", "received"], "article_id"=>385820, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_adverse_events_up_to_day_28_for_patients_having_received_at_least_one_dose_/385820", "title"=>"Summary of adverse events up to day 28 (for patients having received at least one dose).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:37:00"}
  • {"files"=>["https://ndownloader.figshare.com/files/715470"], "description"=>"<p>Values are hazard ratio (95% CI) or OR (95% CI), as indicated.</p>a<p>Hazard ratio of treatment (first listed) versus control.</p>b<p>Analysis based on zero-inflated Poisson models reported as the OR of excess gametocytes during follow-up, and the ratio of gametocyte carriage days (for those with gametocytes).</p>c<p>Mean change (difference) between day 0 and day of follow-up.</p>", "links"=>[], "tags"=>["outcomes", "pair-wise"], "article_id"=>385847, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Secondary_outcomes_by_pair_wise_comparison_/385847", "title"=>"Secondary outcomes by pair-wise comparison.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:37:27"}
  • {"files"=>["https://ndownloader.figshare.com/files/715494"], "description"=>"<p>Liver function: alanine aminotransferase (ALAT; IU/l); renal function: creatinine (µmol/l). Sample size indicated in the denominator of proportions of values above the normal range.</p><p>IQR, interquartile range.</p>", "links"=>[], "tags"=>["renal"], "article_id"=>385867, "categories"=>["Infectious Diseases"], "users"=>["The Four Artemisinin-Based Combinations (4ABC) Study Group"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001119.t006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Biochemistry_tests_for_liver_and_renal_function_before_and_after_treatment_/385867", "title"=>"Biochemistry tests for liver and renal function before and after treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-08 01:37:47"}

PMC Usage Stats | Further Information

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