About the Authors
- Julie A Simpson
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*To whom correspondence should be addressed. E-mail: julieas@unimelb.edu.au
Affiliation Centre for Molecular, Environmental, Genetic and Analytic Epidemiology, The University of Melbourne, Melbourne, Australia
- Tsiri Agbenyega
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Affiliation School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
- Karen I Barnes
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Affiliation Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa
- Gianni Di Perri
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Affiliation Clinica di Malattie Infecttive, Ospedale Amedeo di Savoia, Torino, Italy
- Peter Folb
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Affiliation South African Medical Research Council, Tygerberg, South Africa
- Melba Gomes
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Affiliation UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland
- Sanjeev Krishna
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Affiliation Division of Cellular and Molecular Medicine, Centre for Infection, University of London, London, United Kingdom
- Srivicha Krudsood
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Affiliation Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
- Sornchai Looareesuwan
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Affiliation Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
- Sharif Mansor
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Affiliation Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia
- Helen McIlleron
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Affiliation Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa
- Raymond Miller
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Affiliation Pfizer Global Research and Development, Ann Arbor, Michigan, United States of America
- Malcolm Molyneux
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Affiliation Malawi-Liverpool-Wellcome Trust Clinical Research Programme and Malaria Project, College of Medicine, Blantyre, Malawi
- James Mwenechanya
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Affiliation Malawi-Liverpool-Wellcome Trust Clinical Research Programme and Malaria Project, College of Medicine, Blantyre, Malawi
- Visweswaran Navaratnam
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Affiliation Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia
- Francois Nosten
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Affiliations Shoklo Malaria Research Unit, Mae-Sot, Tak, Thailand , Wellcome Trust Mahidol University Oxford Tropical Medicine Research Programme, Mahidol University, Bangkok, Thailand
- Piero Olliaro
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Affiliations UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland , Centre for Tropical Medicine and Vaccinology, Churchill Hospital, University of Oxford, United Kingdom
- Lorrin Pang
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Affiliation Department of Health, Maui County, Hawaii, United States of America
- Isabela Ribeiro
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Affiliation UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland
- Madalitso Tembo
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Affiliation Malawi-Liverpool-Wellcome Trust Clinical Research Programme and Malaria Project, College of Medicine, Blantyre, Malawi
- Michele van Vugt
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Affiliations Shoklo Malaria Research Unit, Mae-Sot, Tak, Thailand , Department of AIDS and Tropical Medicine, Amsterdam Medical Center, Amsterdam, Netherlands
- Steve Ward
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Affiliation Liverpool School of Tropical Medicine, Liverpool, United Kingdom
- Kris Weerasuriya
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Affiliation Regional Office for South-East Asia, World Health Organization, New Delhi, India
- Kyaw Win
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Affiliation State Peace and Development Council, Myanmar
- Nicholas J White
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Affiliations Wellcome Trust Mahidol University Oxford Tropical Medicine Research Programme, Mahidol University, Bangkok, Thailand , Centre for Tropical Medicine and Vaccinology, Churchill Hospital, University of Oxford, United Kingdom
Competing Interests
M. Gomes works for the World Health Organization, sponsor of the studies, and was involved in the decision to submit the manuscript for publication. During the study, K. Weerasuriya worked part-time for the World Health Organization, and is now employed full-time.
Author Contributions
J. Simpson analysed the data and wrote the paper. G. Di Perri, M. Gomes, R. Miller, M. Molyneux, V. Navaratnam, F. Nosten, P. Olliaro, L. Pang, I. Ribeiro, K. Weerasuriya, K. Win, S. Ward, and N. White designed the study. G. Di Perri, P. Folb, S. Mansor, M. Molyneux, I. Ribeiro, K. Win, and N. White analysed the data. T. Agbenyega, K. Barnes, S. Krishna, S. Krudsood, S. Looareesuwan, H. McIlleron, M. Molyneux, J. Mwenechanya, F. Nosten, M. Tembo, and M. van Vugt enrolled patients. H. McIlleron and F. Nosten collected data and did experiments. K. Barnes, G. Di Perri, P. Folb, M. Gomes, S. Krishna, S. Mansor, H. McIlleron, M. Molyneux, V. Navaratnam, F. Nosten, P. Olliaro, I. Ribeiro, M. van Vugt, and N. White contributed to writing the paper. K. Barnes adapted the study designed by the rectal artesunate task force to suit the South African context and was the principal investigator of the study in South Africa. M. Gomes managed the WHO Task Force, which designed the studies. This involved the review of protocols and case record forms, coordination and overall management of the studies, management of the samples for kinetic analyses, provision of individual study reports to regulatory authorities, provision of data and study protocols to the corresponding author for analysis, response to data queries, and contribution to the writing of the paper. S. Krudsood cared for all of the participants (Bangkok site) and managed the case record forms. S. Looareesuwan was the principle investigator for the Bangkok site. M. Molyneux analysed the clinical components of the data, reviewed the pharmacokinetic data, and also administered drugs, collected, stored, and dispatched pharmacokinetic samples, and observed, recorded, and analysed bedside and laboratory outcome measures for the Malawi group of patients. S. Mansor conducted the chromatographic assay and also the drug and pharmacokinetic analysis. R. Miller helped with the pharmacokinetic analysis of the data. J. Mwenechanya was responsible for sample collection, data entry, and patient follow-up post study. V. Navaratnam undertook the analysis of patient samples for drug levels and carried out basic pharmacokinetic analysis. L. Pang helped establish one of the field sites and convinced local investigators and sponsoring agencies of the feasibility, value, and ethical appropriateness of such a study. M. van Vugt was the treating physician in Mae-Sot. K. Weerasuriya contributed to the study design by developing the clinical trial protocol, and contributed to data collection by monitoring the clinical trial and some logistics in the specialized transport of specimens. K. Win was involved in the formulation of the first artesunate rectal capsules, was the first applicant for a TDR grant for clinical and kinetic studies, and participated in the TDR meetings for designing the early studies in 1995.