Susceptibility of Southeast Asian Plasmodium falciparum isolates to P218
Navaporn PosayapisitJutharat PengonPhilip J. ShawChairat UthaipibullDarin KongkasuriyachaiAung Pyae PhyoFrançois NostenYongyuth YuthavongSumalee Kamchonwongpaisan
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A study on efficacy and effectiveness of artemisinin (total dose of 60 mg/kg) and artesunate (total dose of 12 mg/kg over five days) in treatment of uncomplicated malaria was conducted in highly malaria transmitted areas in Vietnam. 126 uncomplicated malaria cases finished 14 day follow-up. 100% cure rate achieved at day 14 in patients of the efficacy groups received either artemisinin or artesunate, while it was 83% and 93% in patients treated respectively with artemisinin and artesunate of the effectiveness groups. Compliance of the treatment regimens was discussed.
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The sensitivity in vitro of Plasmodium falciparum to mefloquine, quinine and artemisinin was assessed in an area of multi-drug resistance on the Thai-Myanmar border, using the World Health Organization's microtest, based on schizont maturation inhibition. Participating individuals were exclusively those who had contracted their infections within Myanmar. A total of 34 successful tests were carried out for mefloquine and quinine, showing a marked decrease in sensitivity compared to previously published results. Ten artemisinin tests were successful, with many failures due to the poor storage stability of the test plates. The implications of the shelf-life of the artemisinin plates is discussed. These results contribute to setting a base line of sensitivity to artemisinin in vitro.
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Journal Article Treatment Of Multidrug-Resistant Plasmodium Falciparum Malaria With 3-Day Artesunate-Mefloquine Combination Get access F. Nosten, F. Nosten Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Reprints or correspondence: Dr. F. Nosten, Shoklo Malaria Research Unit. P.O. Box 46. Mae Sot. 63110 Thailand. Fax: (66) 55532637. Search for other works by this author on: Oxford Academic PubMed Google Scholar C. Luxemburger, C. Luxemburger Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar F. O. ter Kuile, F. O. ter Kuile Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar C. Woodrow, C. Woodrow Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar J. Pa Eh, J. Pa Eh Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar T. Chongsuphajaisiddhi, T. Chongsuphajaisiddhi Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar N. J. White N. J. White Shoklo Malaria Research Unit, Mae Sot, and Faculty of Tropical Medicine, Mahidol UniversityBangkok, ThailandUnit of Infectious Diseases and Tropical Medicine, Academic Medical Centre, University of AmsterdamNetherlandsCentre for Tropical Medicine, Nuffield Department of Clinical Medicine, John Radcliffe HospitalHeadington, Oxford, United Kingdom Search for other works by this author on: Oxford Academic PubMed Google Scholar The Journal of Infectious Diseases, Volume 170, Issue 4, October 1994, Pages 971–977, https://doi.org/10.1093/infdis/170.4.971 Published: 01 October 1994 Article history Received: 28 December 1993 Revision received: 13 April 1994 Published: 01 October 1994
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A markedly high failure rate of three-day artesunate-mefloquine was observed in the area along the Thai-Myanmar border. Identification of Plasmodium falciparum isolates with intrinsic resistance to each component of the artesunate-mefloquine combination was analysed with integrated information on clinico-parasitological response, together with systemic drug exposure (area under blood/plasma concentration-time curves (AUC)) of dihydroartemisinin and mefloquine, and in vitro sensitivity of P. falciparum in a total of 17 out of 29 P. falciparum isolates from patients with acute uncomplicated falciparum malaria. Analysis of the contribution of in vitro parasite sensitivity and systemic drug exposure and relationship with pfmdr1 copy number in the group with sensitive response was performed in 21 of 69 cases. Identification of resistance and/or reduced intrinsic parasitocidal activity of artesunate and/or mefloquine without pharmacokinetic or other host-related factors were confirmed in six cases: one with reduced sensitivity to artesunate alone, two with resistance to mefloquine alone, and three with reduced sensitivity to artesunate combined with resistance to mefloquine. Resistance and/or reduced intrinsic parasitocidal activity of mefloquine/artesunate, together with contribution of pharmacokinetic factor of mefloquine and/or artesunate were identified in seven cases: two with resistance to mefloquine alone, and five with resistance to mefloquine combined with reduced sensitivity to artesunate. Pharmacokinetic factor alone contributed to recrudescence in three cases, all of which had inadequate whole blood mefloquine levels (AUC0-7days). Other host-related factors contributed to recrudescence in one case. Amplification of pfmdr1 (increasing of pfmdr1 copy number) is a related molecular marker of artesunate-mefloquine resistance and seems to be a suitable molecular marker to predict occurrence of recrudescence. Despite the evidence of a low level of a decline in sensitivity of P. falciparum isolates to artemisinins in areas along the Thai-Myanmar border, artemisinin-based combination therapy (ACT) would be expected to remain the key anti-malarial drug for treatment of multidrug resistance P. falciparum. Continued monitoring and active surveillance of clinical efficacy of ACT, including identification of true artemisinin resistant parasites, is required for appropriate implementation of malaria control policy in this area.
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Abstract Background Mefloquine and artesunate combination therapy is the recommended first-line treatment for uncomplicated malaria throughout much of south-east Asia. Concerns have been raised about the potential central nervous system (CNS) effects of both drug components and there are no detailed reports in very young children. Methods Children, aged between three months and five years, with acute uncomplicated Plasmodium falciparum malaria were randomized to either 7 days of artesunate monotherapy or the same schedule of artesunate plus mefloquine on day 7 and 8. Neurological testing targeting coordination and behaviour was carried out at day 0, 7, 9, 10, 14 and 28. Non-febrile healthy control children from the same population were tested on days 0, 7, 14 and 28. Results From December 1994 to July 1997, 91 children with uncomplicated P. falciparum , 45 treated with artesunate monotherapy, 46 treated with mefloquine and artesunate combination therapy and 36 non-febrile controls, underwent neurological testing. Malaria and fever had a significant negative impact on testing performance. By contrast, the anti-malarial treatments were not associated with worsening performances in the various components of the test. Artesunate and mefloquine do not appear to have a significant influence on coordination and behaviour. Children treated with mefloquine were significantly less likely to suffer recurrent malaria infection during follow-up compared to those treated with artesunate alone (P = 0.033). Conclusion In keeping with the results of randomized controlled trials in adults, mefloquine was not associated with a decrease in specific items of neurological performance. Likewise, children treated with artesunate did not perform significantly differently to control children. This study does not exclude subtle or rare treatment CNS effects of artesunate or mefloquine. Treatment of acute uncomplicated malaria results in a significant improvement on items of neurological performance.
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Clinical data on the use of artesunate combined with mefloquine in a variety of treatment regimens and parasite loads in Thailand were modelled on the basis of experimentally determined pharmacokinetic data. The model assumed no pharmacodynamic interaction between artesunate and mefloquine, but that the parasites were already resistant to mefloquine. Predictions of the model accorded well with the data. In particular, in accordance with clinical observations, the model showed that monotherapy with either drug failed to cure at moderate parasitaemia, yet such patients could be treated effectively with the combination of 3 days of artesunate + mefloquine. For high levels of parasitaemia, 5 days of artesunate+mefloquine were needed. Simulations were also performed for situations of lower resistance to mefloquine and for the immune human populations found in Africa. The importance of mathematical modelling of combination therapy is borne out by this study and suggests its wider application for other drug combinations.
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