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Publication Metadata only Personalised randomised controlled trial designs—a new paradigm to define optimal treatments for carbapenem-resistant infections(2021-06-01) A. Sarah Walker; Ian R. White; Rebecca M. Turner; Li Yang Hsu; Tsin Wen Yeo; Nicholas J. White; Mike Sharland; Guy E. Thwaites; Faculty of Tropical Medicine, Mahidol University; Oxford University Clinical Research Unit; St George’s, University of London; National University of Singapore; Nuffield Department of Medicine; Nanyang Technological University; MRC Clinical Trials Unitaeruginosa. Numerous areas of clinical uncertainty surround the treatment of these highly resistant infections, yet substantial obstacles exist to the design and conduct of treatment trials for carbapenem-resistant bacterial infections. These include the lack... of a widely acceptable optimised standard of care and control regimens, varying antimicrobial susceptibilities and clinical contraindications making specific intervention regimens infeasible, and diagnostic and recruitment challenges. The current singlePublication Metadata only Participants' perceptions and understanding of a malaria clinical trial in Bangladesh(2014-06-04) Debashish Das; Phaik Yeong Cheah; Fateha Akter; Dulal Paul; Akhterul Islam; Abdullah A. Sayeed; Rasheda Samad; Ridwanur Rahman; Amir Hossain; Arjen Dondorp; Nicholas P. Day; Nicholas J. White; Mahtabuddin Hasan; Aniruddha Ghose; Elizabeth A. Ashley; Abul Faiz; Mahidol University; Nuffield Department of Clinical Medicine; Chittagong Medical College Hospital; Cox's Bazar Medical College; Upazila Health Complex; Shaheed Suhrawardy Medical College; Malaria Research Group and Dev Care FoundationBackground: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study..., specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods. In this study semi-structuredPublication Metadata only The arrhythmogenic cardiotoxicity of the quinoline and structurally related antimalarial drugs: A systematic review(2018-11-07) Ilsa L. Haeusler; Xin Hui S. Chan; Philippe J. Guérin; Nicholas J. White; NHS Foundation Trust; Mahidol University; Nuffield Department of Clinical Medicine; WorldWide Antimalarial Resistance Network (WWARN)did not allow pooled quantitative analysis of QT interval changes. Conclusions: No serious cardiac adverse effects were recorded in malaria clinical trials of 35,548 participants who received quinoline and structurally related antimalarials with close... rapidly highlights the need to review their cardiovascular safety profiles. Methods: The primary objective of this systematic review was to describe the documented clinical and electrocardiographic cardiovascular side effects of quinine, mefloquinePublication Metadata only Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: Maintained efficacy a decade after introduction(2016-02-25) Ghulam Rahim Awab; Mallika Imwong; Sasithon Pukrittayakamee; Fazel Alim; Warunee Hanpithakpong; Joel Tarning; Arjen M. Dondorp; Nicholas P.J. Day; Nicholas J. White; Charles J. Woodrow; Mahidol University; Ministry of Public Health; Nuffield Department of Clinical Medicineefficacy was high in all the trials, with an adequate clinical and parasitological response (ACPR) of more than 95 % in all groups and trial stages. Genotyping for drug-resistance alleles at dhfr indicated fixation of the S108 N mutation and a prevalence...© 2016 Awab et al. Background: Combination therapy with artesunate plus sulfadoxine-pyrimethamine (SP) was adopted as recommended treatment for Plasmodium falciparum infection in Afghanistan in 2003. Methods: A series of prospective clinical studiesPublication Metadata only Editorial: Clinical trials in tropical diseases: A politically incorrect view(2006-10-01) Nicholas J. White; Mahidol UniversityPublication Metadata only Revisiting the design of phase III clinical trials of antimalarial drugs for uncomplicated Plasmodium falciparum malaria(2008-11-01) Steffen Borrmann; Tim Peto; Robert W. Snow; Win Gutteridge; Nicholas J. White; Kenya Medical Research Institute; Universitat Heidelberg; John Radcliffe Hospital; University of Oxford; Medicines for Malaria Venture; Mahidol UniversityPublication Metadata only Defining surrogate endpoints for clinical trials in severe falciparum malaria(2017-01-01) Atthanee Jeeyapant; Hugh W. Kingston; Katherine Plewes; Richard J. Maude; Josh Hanson; M. Trent Herdman; Stije J. Leopold; Thatsanun Ngernseng; Prakaykaew Charunwatthana; Nguyen Hoan Phu; Aniruddha Ghose; M. Mahtab Uddin Hasan; Caterina I. Fanello; Md Abul Faiz; Tran Tinh Hien; Nicholas P.J. Day; Nicholas J. White; Arjen M. Dondorp; Mahidol University; Charles Darwin University; Nuffield Department of Clinical Medicine; Menzies School of Health Research; UCL; Chittagong Medical College Hospital; Universite de Kinshasa; Dev Care Foundationare credited. Background Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint... for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. Methods Three datasets of clinical studies in severePublication Metadata only Quality assurance of drugs used in clinical trials: Proposal for adapting guidelines(2015-02-25) Paul N. Newton; David Schellenberg; Elizabeth A. Ashley; Raffaella Ravinetto; Michael D. Green; Feiko O. Ter Kuile; Patricia Tabernero; Nicholas J. White; Philippe J. Guerin; Mahosot Hospital; London School of Hygiene & Tropical Medicine; Mahidol University; Prins Leopold Instituut voor Tropische Geneeskunde; Centers for Disease Control and Prevention; Liverpool School of Tropical Medicine; University of Oxford; Churchill HospitalPublication Metadata only The use of ultrasensitive quantitative-PCR to assess the impact of primaquine on asymptomatic relapse of Plasmodium vivax infections: a randomized, controlled trial in Lao PDR(2020-01-03) Koukeo Phommasone; Frank van Leth; Mallika Imwong; Gisela Henriques; Tiengkham Pongvongsa; Bipin Adhikari; Thomas J. Peto; Cholrawee Promnarate; Mehul Dorda; Pasathorn Sirithiranont; Mavuto Mukaka; Pimnara Peerawaranun; Nicholas P.J. Day; Frank Cobelens; Arjen M. Dondorp; Paul N. Newton; Nicholas J. White; Lorenz von Seidlein; Mayfong Mayxay; Mahidol University; Nuffield Department of Clinical Medicine; Amsterdam UMC - University of Amsterdam; Amsterdam Institute for Global Health and Development; Mahosot Hospital; Savannakhet Provincial Health Department; University of Health Scienceswas registered with ClinicalTrials.gov under NCT02802813 on 16th June 2016. https://clinicaltrials.gov/ct2/show/NCT02802813....BACKGROUND: Trials to assess the efficacy of the radical cure of Plasmodium vivax malaria with 8-aminoquinolines require that most post-treatment relapses are identified, but there is no consensus on the optimal duration of follow-up in eitherPublication Metadata only Pharmacokinetic-pharmacodynamic assessment of the hepatic and bone marrow toxicities of the new trypanoside fexinidazole(2019-04-01) James A. Watson; Nathalie Strub-Wourgraft; Antoine Tarral; Isabela Ribeiro; Joel Tarning; Nicholas J. White; Mahidol University; Nuffield Department of Clinical Medicine; Drugs for Neglected Diseases Initiativeof hepatotoxicity was observed in patients with g-HAT. Fexinidazole treatment results in a dose-dependent liver toxicity and transient bone marrow suppression in Chagas disease patients. Regimens of shorter duration should be evaluated in clinical trials... the course of a dose ranging assessment in patients with chronic indeterminate Chagas disease, delayed neutropenia and significant increases in hepatic transaminases were observed and clinical investigations were suspended. We retrospectively analyzed all