Publication:
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

1

Issued Date

2015-09-07

Resource Type

Article

ISSN

17417015

DOI

10.1186/s12916-015-0445-x

Other identifier(s)

2-s2.0-84941618712

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

BMC Medicine. Vol.13, No.1 (2015)

Suggested Citation

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. BMC Medicine. Vol.13, No.1 (2015). doi:10.1186/s12916-015-0445-x Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/36334

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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

Author(s)

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

Other Contributor(s)

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

Abstract

© 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.

Keyword(s)

Medicine

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https://repository.li.mahidol.ac.th/handle/123456789/36334

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Scopus 2011-2015