Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data
© 2015 WWARN Artemisinin based Combination Therapy (ACT) Africa Baseline Study Group. Background: Artemisinin-resistant Plasmodium falciparum has emerged in the Greater Mekong sub-region and poses a major global public health threat. Slow parasite clearance is a key clinical manifestation of reduced...
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Medicine Salim Abdulla Ishag Adam George O. Adjei Martin A. Adjuik Bereket Alemayehu Richard Allan Emmanuel Arinaitwe Elizabeth A. Ashley Mamadou S. Ba Hubert Barennes Karen I. Barnes Quique Bassat Elisabeth Baudin Nicole Berens-Riha Anders Björkman François Bompart Maryline Bonnet Steffen Borrmann Teun Bousema Philippe Brasseur Hasifa Bukirwa Francesco Checchi Prabin Dahal Umberto D'Alessandro Meghna Desai Alassane Dicko Abdoulaye A. Djimdé Grant Dorsey Ogobara K. Doumbo Chris J. Drakeley Stephan Duparc Teferi Eshetu Emmanuelle Espié Jean François Etard Abul M. Faiz Catherine O. Falade Caterina I. Fanello Jean François Faucher Babacar Faye Oumar Faye Scott Filler Jennifer A. Flegg Bakary Fofana Carole Fogg Nahla B. Gadalla Oumar Gaye Blaise Genton Peter W. Gething José P. Gil Raquel González Francesco Grandesso Bryan Greenhouse Brian Greenwood Anastasia Grivoyannis Philippe J. Guerin Jean Paul Guthmann Kamal Hamed Sally Hamour Simon I. Hay Eva Maria Hodel Georgina S. Humphreys Jimee Hwang Maman L. Ibrahim Daddi Jima Joel J. Jones Vincent Jullien Elizabeth Juma Patrick S. Kachur Piet A. Kager Erasmus Kamugisha Moses R. Kamya Corine Karema Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
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© 2015 WWARN Artemisinin based Combination Therapy (ACT) Africa Baseline Study Group. Background: Artemisinin-resistant Plasmodium falciparum has emerged in the Greater Mekong sub-region and poses a major global public health threat. Slow parasite clearance is a key clinical manifestation of reduced susceptibility to artemisinin. This study was designed to establish the baseline values for clearance in patients from Sub-Saharan African countries with uncomplicated malaria treated with artemisinin-based combination therapies (ACTs). Methods: A literature review in PubMed was conducted in March 2013 to identify all prospective clinical trials (uncontrolled trials, controlled trials and randomized controlled trials), including ACTs conducted in Sub-Saharan Africa, between 1960 and 2012. Individual patient data from these studies were shared with the WorldWide Antimalarial Resistance Network (WWARN) and pooled using an a priori statistical analytical plan. Factors affecting early parasitological response were investigated using logistic regression with study sites fitted as a random effect. The risk of bias in included studies was evaluated based on study design, methodology and missing data. Results: In total, 29, 493 patients from 84 clinical trials were included in the analysis, treated with artemether-lumefantrine (n = 13, 664), artesunate-amodiaquine (n = 11, 337) and dihydroartemisinin-piperaquine (n = 4, 492). The overall parasite clearance rate was rapid. The parasite positivity rate (PPR) decreased from 59.7 % (95 % CI: 54.5-64.9) on day 1 to 6.7 % (95 % CI: 4.8-8.7) on day 2 and 0.9 % (95 % CI: 0.5-1.2) on day 3. The 95th percentile of observed day 3 PPR was 5.3 %. Independent risk factors predictive of day 3 positivity were: high baseline parasitaemia (adjusted odds ratio (AOR) = 1.16 (95 % CI: 1.08-1.25); per 2-fold increase in parasite density, P <0.001); fever (>37.5 °C) (AOR = 1.50 (95 % CI: 1.06-2.13), P = 0.022); severe anaemia (AOR = 2.04 (95 % CI: 1.21-3.44), P = 0.008); areas of low/moderate transmission setting (AOR = 2.71 (95 % CI: 1.38-5.36), P = 0.004); and treatment with the loose formulation of artesunate-amodiaquine (AOR = 2.27 (95 % CI: 1.14-4.51), P = 0.020, compared to dihydroartemisinin-piperaquine). Conclusions: The three ACTs assessed in this analysis continue to achieve rapid early parasitological clearance across the sites assessed in Sub-Saharan Africa. A threshold of 5 % day 3 parasite positivity from a minimum sample size of 50 patients provides a more sensitive benchmark in Sub-Saharan Africa compared to the current recommended threshold of 10 % to trigger further investigation of artemisinin susceptibility. |
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Ifakara Health Institute |
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Ifakara Health Institute Salim Abdulla Ishag Adam George O. Adjei Martin A. Adjuik Bereket Alemayehu Richard Allan Emmanuel Arinaitwe Elizabeth A. Ashley Mamadou S. Ba Hubert Barennes Karen I. Barnes Quique Bassat Elisabeth Baudin Nicole Berens-Riha Anders Björkman François Bompart Maryline Bonnet Steffen Borrmann Teun Bousema Philippe Brasseur Hasifa Bukirwa Francesco Checchi Prabin Dahal Umberto D'Alessandro Meghna Desai Alassane Dicko Abdoulaye A. Djimdé Grant Dorsey Ogobara K. Doumbo Chris J. Drakeley Stephan Duparc Teferi Eshetu Emmanuelle Espié Jean François Etard Abul M. Faiz Catherine O. Falade Caterina I. Fanello Jean François Faucher Babacar Faye Oumar Faye Scott Filler Jennifer A. Flegg Bakary Fofana Carole Fogg Nahla B. Gadalla Oumar Gaye Blaise Genton Peter W. Gething José P. Gil Raquel González Francesco Grandesso Bryan Greenhouse Brian Greenwood Anastasia Grivoyannis Philippe J. Guerin Jean Paul Guthmann Kamal Hamed Sally Hamour Simon I. Hay Eva Maria Hodel Georgina S. Humphreys Jimee Hwang Maman L. Ibrahim Daddi Jima Joel J. Jones Vincent Jullien Elizabeth Juma Patrick S. Kachur Piet A. Kager Erasmus Kamugisha Moses R. Kamya Corine Karema |
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Salim Abdulla Ishag Adam George O. Adjei Martin A. Adjuik Bereket Alemayehu Richard Allan Emmanuel Arinaitwe Elizabeth A. Ashley Mamadou S. Ba Hubert Barennes Karen I. Barnes Quique Bassat Elisabeth Baudin Nicole Berens-Riha Anders Björkman François Bompart Maryline Bonnet Steffen Borrmann Teun Bousema Philippe Brasseur Hasifa Bukirwa Francesco Checchi Prabin Dahal Umberto D'Alessandro Meghna Desai Alassane Dicko Abdoulaye A. Djimdé Grant Dorsey Ogobara K. Doumbo Chris J. Drakeley Stephan Duparc Teferi Eshetu Emmanuelle Espié Jean François Etard Abul M. Faiz Catherine O. Falade Caterina I. Fanello Jean François Faucher Babacar Faye Oumar Faye Scott Filler Jennifer A. Flegg Bakary Fofana Carole Fogg Nahla B. Gadalla Oumar Gaye Blaise Genton Peter W. Gething José P. Gil Raquel González Francesco Grandesso Bryan Greenhouse Brian Greenwood Anastasia Grivoyannis Philippe J. Guerin Jean Paul Guthmann Kamal Hamed Sally Hamour Simon I. Hay Eva Maria Hodel Georgina S. Humphreys Jimee Hwang Maman L. Ibrahim Daddi Jima Joel J. Jones Vincent Jullien Elizabeth Juma Patrick S. Kachur Piet A. Kager Erasmus Kamugisha Moses R. Kamya Corine Karema |
author_sort |
Salim Abdulla |
title |
Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
title_short |
Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
title_full |
Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
title_fullStr |
Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
title_full_unstemmed |
Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data |
title_sort |
clinical determinants of early parasitological response to acts in african patients with uncomplicated falciparum malaria: a literature review and meta-analysis of individual patient data |
publishDate |
2018 |
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https://repository.li.mahidol.ac.th/handle/123456789/36334 |
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1763496598503948288 |
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th-mahidol.363342018-11-23T17:36:46Z Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: A literature review and meta-analysis of individual patient data Salim Abdulla Ishag Adam George O. Adjei Martin A. Adjuik Bereket Alemayehu Richard Allan Emmanuel Arinaitwe Elizabeth A. Ashley Mamadou S. Ba Hubert Barennes Karen I. Barnes Quique Bassat Elisabeth Baudin Nicole Berens-Riha Anders Björkman François Bompart Maryline Bonnet Steffen Borrmann Teun Bousema Philippe Brasseur Hasifa Bukirwa Francesco Checchi Prabin Dahal Umberto D'Alessandro Meghna Desai Alassane Dicko Abdoulaye A. Djimdé Grant Dorsey Ogobara K. Doumbo Chris J. Drakeley Stephan Duparc Teferi Eshetu Emmanuelle Espié Jean François Etard Abul M. Faiz Catherine O. Falade Caterina I. Fanello Jean François Faucher Babacar Faye Oumar Faye Scott Filler Jennifer A. Flegg Bakary Fofana Carole Fogg Nahla B. Gadalla Oumar Gaye Blaise Genton Peter W. Gething José P. Gil Raquel González Francesco Grandesso Bryan Greenhouse Brian Greenwood Anastasia Grivoyannis Philippe J. Guerin Jean Paul Guthmann Kamal Hamed Sally Hamour Simon I. Hay Eva Maria Hodel Georgina S. Humphreys Jimee Hwang Maman L. Ibrahim Daddi Jima Joel J. Jones Vincent Jullien Elizabeth Juma Patrick S. Kachur Piet A. Kager Erasmus Kamugisha Moses R. Kamya Corine Karema Ifakara Health Institute University of Khartoum Faculty of Medicine University of Ghana INDEPTH Network International Center for AIDS Care and Treatment Programs MENTOR Initiative Infectious Diseases Research Collaboration Epicentre Universite Cheikh Anta Diop Centre MURAZ French Foreign Affairs WorldWide Antimalarial Resistance Network University of Cape Town Centro de Investigação em Saúde de Manhiça Instituto de Salud Global de Barcelona Ludwig-Maximilians-Universitat Munchen Karolinska University Hospital Sanofi S.A. Kenya Medical Research Institute Universitat Tubingen German Centre for Infection Research London School of Hygiene & Tropical Medicine Radboud University Nijmegen Medical Centre Institut de Recherche pour le Developpement Dakar Uganda Malaria Surveillance Project WorldWide Antimalarial Resistance Network (WWARN) Nuffield Department of Clinical Medicine Prins Leopold Instituut voor Tropische Geneeskunde Medical Research Council Unit Centers for Disease Control and Prevention University of Bamako Faculty of Medicine, Pharmacy and Odonto-Stomatology University of California, San Francisco Medicines for Malaria Venture Jimma University IRD Centre de Montpellier Mahidol University University of Ibadan IRD Institut de Recherche pour le Developpement Universite Paris Descartes Besançon University Medical Center The Global Fund to Fight AIDS, Tuberculosis and Malaria Monash University Portsmouth Hospitals NHS Trust Tropical Medicine Research Institute Sudan National Institute of Allergy and Infectious Diseases Swiss Tropical and Public Health Institute (Swiss TPH) Centre Hospitalier Universitaire Vaudois University of Oxford Karolinska Institutet Faculdade de Ciencias, Universidade de Lisboa Binghamton University State University of New York University of Washington, Seattle Institut de Veille Sanitaire Novartis Pharmaceuticals Corporation UCL Wellcome Trust Centre for Human Genetics National Institutes of Health, Bethesda Liverpool School of Tropical Medicine Centre de Recherche Médicale et Sanitaire Federal Ministry of Health - Ethiopia Ministry of Health and Social Welfare Academic Medical Centre, University of Amsterdam Catholic University of Health and Allied Sciences Makerere University Ministry of Health Drugs for Neglected Diseases Initiative Projecto de Saúde de Bandim Kolding Sygehus Centre de Recherches Médicales de Lambaréné University of London Médecins Sans Frontières European & Developing Countries Clinical Trials Partnership Federal Ministry of Health Sudan Uppsala Universitet University of Abomey-Calavi University of Cocody Institut Pasteur du Cambodge Royal Tropical Institute - KIT University of Calabar Institute of Tropical Diseases Research and Prevention Mbarara University of Science and Technology Tropical Diseases Research Centre Muhimbili University of Health and Allied Sciences Institut de Recherche en Sciences de la Santé Universite Marien Ngouabi Medicine © 2015 WWARN Artemisinin based Combination Therapy (ACT) Africa Baseline Study Group. Background: Artemisinin-resistant Plasmodium falciparum has emerged in the Greater Mekong sub-region and poses a major global public health threat. Slow parasite clearance is a key clinical manifestation of reduced susceptibility to artemisinin. This study was designed to establish the baseline values for clearance in patients from Sub-Saharan African countries with uncomplicated malaria treated with artemisinin-based combination therapies (ACTs). Methods: A literature review in PubMed was conducted in March 2013 to identify all prospective clinical trials (uncontrolled trials, controlled trials and randomized controlled trials), including ACTs conducted in Sub-Saharan Africa, between 1960 and 2012. Individual patient data from these studies were shared with the WorldWide Antimalarial Resistance Network (WWARN) and pooled using an a priori statistical analytical plan. Factors affecting early parasitological response were investigated using logistic regression with study sites fitted as a random effect. The risk of bias in included studies was evaluated based on study design, methodology and missing data. Results: In total, 29, 493 patients from 84 clinical trials were included in the analysis, treated with artemether-lumefantrine (n = 13, 664), artesunate-amodiaquine (n = 11, 337) and dihydroartemisinin-piperaquine (n = 4, 492). The overall parasite clearance rate was rapid. The parasite positivity rate (PPR) decreased from 59.7 % (95 % CI: 54.5-64.9) on day 1 to 6.7 % (95 % CI: 4.8-8.7) on day 2 and 0.9 % (95 % CI: 0.5-1.2) on day 3. The 95th percentile of observed day 3 PPR was 5.3 %. Independent risk factors predictive of day 3 positivity were: high baseline parasitaemia (adjusted odds ratio (AOR) = 1.16 (95 % CI: 1.08-1.25); per 2-fold increase in parasite density, P <0.001); fever (>37.5 °C) (AOR = 1.50 (95 % CI: 1.06-2.13), P = 0.022); severe anaemia (AOR = 2.04 (95 % CI: 1.21-3.44), P = 0.008); areas of low/moderate transmission setting (AOR = 2.71 (95 % CI: 1.38-5.36), P = 0.004); and treatment with the loose formulation of artesunate-amodiaquine (AOR = 2.27 (95 % CI: 1.14-4.51), P = 0.020, compared to dihydroartemisinin-piperaquine). Conclusions: The three ACTs assessed in this analysis continue to achieve rapid early parasitological clearance across the sites assessed in Sub-Saharan Africa. A threshold of 5 % day 3 parasite positivity from a minimum sample size of 50 patients provides a more sensitive benchmark in Sub-Saharan Africa compared to the current recommended threshold of 10 % to trigger further investigation of artemisinin susceptibility. 2018-11-23T10:36:46Z 2018-11-23T10:36:46Z 2015-09-07 Article BMC Medicine. Vol.13, No.1 (2015) 10.1186/s12916-015-0445-x 17417015 2-s2.0-84941618712 https://repository.li.mahidol.ac.th/handle/123456789/36334 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84941618712&origin=inward |