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https://www.readbyqxmd.com/read/28841864/comparison-of-statistical-models-to-estimate-parasite-growth-rate-in-the-induced-blood-stage-malaria-model
#1
Leesa F Wockner, Isabell Hoffmann, Peter O'Rourke, James S McCarthy, Louise Marquart
BACKGROUND: The efficacy of vaccines aimed at inhibiting the growth of malaria parasites in the blood can be assessed by comparing the growth rate of parasitaemia in the blood of subjects treated with a test vaccine compared to controls. In studies using induced blood stage malaria (IBSM), a type of controlled human malaria infection, parasite growth rate has been measured using models with the intercept on the y-axis fixed to the inoculum size. A set of statistical models was evaluated to determine an optimal methodology to estimate parasite growth rate in IBSM studies...
August 25, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28820709/performance-of-a-high-sensitivity-rapid-diagnostic-test-for-plasmodium-falciparum-malaria-in-asymptomatic-individuals-from-uganda-and-myanmar-and-naive-human-challenge-infections
#2
Smita Das, Ihn Kyung Jang, Becky Barney, Roger Peck, John C Rek, Emmanuel Arinaitwe, Harriet Adrama, Maxwell Murphy, Mallika Imwong, Clare L Ling, Stephane Proux, Warat Haohankhunnatham, Melissa Rist, Annette M Seilie, Amelia Hanron, Glenda Daza, Ming Chang, Tomoka Nakamura, Michael Kalnoky, Paul Labarre, Sean C Murphy, James S McCarthy, Francois Nosten, Bryan Greenhouse, Sophie Allauzen, Gonzalo J Domingo
Sensitive field-deployable diagnostic tests can assist malaria programs in achieving elimination. The performance of a new Alere™ Malaria Ag P.f Ultra Sensitive rapid diagnostic test (uRDT) was compared with the currently available SD Bioline Malaria Ag P.f RDT in blood specimens from asymptomatic individuals in Nagongera, Uganda, and in a Karen Village, Myanmar, representative of high- and low-transmission areas, respectively, as well as in pretreatment specimens from study participants from four Plasmodium falciparum-induced blood-stage malaria (IBSM) studies...
August 7, 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28363636/safety-tolerability-pharmacokinetics-and-activity-of-the-novel-long-acting-antimalarial-dsm265-a-two-part-first-in-human-phase-1a-1b-randomised-study
#3
RANDOMIZED CONTROLLED TRIAL
James S McCarthy, Julie Lotharius, Thomas Rückle, Stephan Chalon, Margaret A Phillips, Suzanne Elliott, Silvana Sekuloski, Paul Griffin, Caroline L Ng, David A Fidock, Louise Marquart, Noelle S Williams, Nathalie Gobeau, Lidiya Bebrevska, Maria Rosario, Kennan Marsh, Jörg J Möhrle
BACKGROUND: DSM265 is a novel antimalarial that inhibits plasmodial dihydroorotate dehydrogenase, an enzyme essential for pyrimidine biosynthesis. We investigated the safety, tolerability, and pharmacokinetics of DSM265, and tested its antimalarial activity. METHODS: Healthy participants aged 18-55 years were enrolled in a two-part study: part 1, a single ascending dose (25-1200 mg), double-blind, randomised, placebo-controlled study, and part 2, an open-label, randomised, active-comparator controlled study, in which participants were inoculated with Plasmodium falciparum induced blood-stage malaria (IBSM) and treated with DSM265 (150 mg) or mefloquine (10 mg/kg)...
June 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/27930652/safety-and-reproducibility-of-a-clinical-trial-system-using-induced-blood-stage-plasmodium-vivax-infection-and-its-potential-as-a-model-to-evaluate-malaria-transmission
#4
Paul Griffin, Cielo Pasay, Suzanne Elliott, Silvana Sekuloski, Maggy Sikulu, Leon Hugo, David Khoury, Deborah Cromer, Miles Davenport, Jetsumon Sattabongkot, Karen Ivinson, Christian Ockenhouse, James McCarthy
BACKGROUND: Interventions to interrupt transmission of malaria from humans to mosquitoes represent an appealing approach to assist malaria elimination. A limitation has been the lack of systems to test the efficacy of such interventions before proceeding to efficacy trials in the field. We have previously demonstrated the feasibility of induced blood stage malaria (IBSM) infection with Plasmodium vivax. In this study, we report further validation of the IBSM model, and its evaluation for assessment of transmission of P...
December 2016: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/27272721/efficacy-of-oz439-artefenomel-against-early-plasmodium-falciparum-blood-stage-malaria-infection-in-healthy-volunteers
#5
James S McCarthy, Mark Baker, Peter O'Rourke, Louise Marquart, Paul Griffin, Rob Hooft van Huijsduijnen, Jörg J Möhrle
OBJECTIVES: OZ439, or artefenomel, is an investigational synthetic ozonide antimalarial with similar potency, but a significantly improved pharmacokinetic profile, compared with artemisinins. We wished to measure key pharmacokinetic and pharmacodynamic parameters and the pharmacokinetic/pharmacodynamic relationship of artefenomel in humans to guide the drug's further development as combination therapy in patients. PATIENTS AND METHODS: We tested artefenomel in the human induced blood-stage malaria (IBSM) model...
September 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27113231/cost-effectiveness-of-internet-based-cognitive-behaviour-therapy-and-behavioural-stress-management-for-severe-health-anxiety
#6
RANDOMIZED CONTROLLED TRIAL
Erik Hedman, Erik Andersson, Brjánn Ljótsson, Erland Axelsson, Mats Lekander
OBJECTIVES: Internet-delivered exposure-based cognitive behaviour therapy (ICBT) has been shown to be effective in the treatment of severe health anxiety. The health economic effects of the treatment have, however, been insufficiently studied and no prior study has investigated the effect of ICBT compared with an active psychological treatment. The aim of the present study was to investigate the cost effectiveness of ICBT compared with internet-delivered behavioural stress management (IBSM) for adults with severe health anxiety defined as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) hypochondriasis...
April 25, 2016: BMJ Open
https://www.readbyqxmd.com/read/27056954/piperaquine-monotherapy-of-drug-susceptible-plasmodium-falciparum-infection-results-in-rapid-clearance-of-parasitemia-but-is-followed-by-the-appearance-of-gametocytemia
#7
Cielo J Pasay, Rebecca Rockett, Silvana Sekuloski, Paul Griffin, Louise Marquart, Christopher Peatey, Claire Y T Wang, Peter O'Rourke, Suzanne Elliott, Mark Baker, Jörg J Möhrle, James S McCarthy
BACKGROUND: Piperaquine, coformulated with dihydroartemisinin, is a component of a widely used artemisinin combination therapy. There is a paucity of data on its antimalarial activity as a single agent. Such data, if available, would inform selection of new coformulations. METHODS: We undertook a study in healthy subjects, using the induced blood stage malaria (IBSM) model to test the antimalarial activity of single doses of piperaquine (960, 640, and 480 mg) in 3 cohorts...
July 1, 2016: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/27044554/linking-murine-and-human-plasmodium-falciparum-challenge-models-in-a-translational-path-for-antimalarial-drug-development
#8
James S McCarthy, Louise Marquart, Silvana Sekuloski, Katharine Trenholme, Suzanne Elliott, Paul Griffin, Rebecca Rockett, Peter O'Rourke, Theo Sloots, Iñigo Angulo-Barturen, Santiago Ferrer, María Belén Jiménez-Díaz, María-Santos Martínez, Rob Hooft van Huijsduijnen, Stephan Duparc, Didier Leroy, Timothy N C Wells, Mark Baker, Jörg J Möhrle
Effective progression of candidate antimalarials is dependent on optimal dosing in clinical studies, which is determined by a sound understanding of pharmacokinetics and pharmacodynamics (PK/PD). Recently, two important translational models for antimalarials have been developed: the NOD/SCID/IL2Rγ(-/-) (NSG) model, whereby mice are engrafted with noninfected and Plasmodium falciparum-infected human erythrocytes, and the induced blood-stage malaria (IBSM) model in human volunteers. The antimalarial mefloquine was used to directly measure the PK/PD in both models, which were compared to previously published trial data for malaria patients...
June 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/25540862/predictors-in-internet-delivered-cognitive-behavior-therapy-and-behavioral-stress-management-for-severe-health-anxiety
#9
RANDOMIZED CONTROLLED TRIAL
Erik Hedman, Erik Andersson, Mats Lekander, Brjánn Ljótsson
Severe health anxiety can be effectively treated with exposure-based Internet-delivered cognitive behavior therapy (ICBT), but information about which factors that predict outcome is scarce. Using data from a recently conducted RCT comparing ICBT (n = 79) with Internet-delivered behavioral stress management (IBSM) (n = 79) the presented study investigated predictors of treatment outcome. Analyses were conducted using a two-step linear regression approach and the dependent variable was operationalized both as end state health anxiety at post-treatment and as baseline-to post-treatment improvement...
January 2015: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/24028826/long-term-outcomes-of-internet-based-self-management-support-in-adults-with-asthma-randomized-controlled-trial
#10
RANDOMIZED CONTROLLED TRIAL
Johanna L van Gaalen, Thijs Beerthuizen, Victor van der Meer, Patricia van Reisen, Geertje W Redelijkheid, Jiska B Snoeck-Stroband, Jacob K Sont
BACKGROUND: Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up...
2013: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/23171672/implementation-strategies-of-internet-based-asthma-self-management-support-in-usual-care-study-protocol-for-the-impasse-cluster-randomized-trial
#11
RANDOMIZED CONTROLLED TRIAL
Johanna L van Gaalen, Moira J Bakker, Leti van Bodegom-Vos, Jiska B Snoeck-Stroband, Willem J J Assendelft, Ad A Kaptein, Victor van der Meer, Christian Taube, Bart P Thoonen, Jacob K Sont
BACKGROUND: Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. METHODS/DESIGN: This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i...
2012: Implementation Science: IS
https://www.readbyqxmd.com/read/23041118/experimentally-induced-blood-stage-malaria-infection-as-a-tool-for-clinical-research
#12
REVIEW
Christian R Engwerda, Gabriela Minigo, Fiona H Amante, James S McCarthy
A system for experimentally induced blood stage malaria infection (IBSM) with Plasmodium falciparum by direct intravenous inoculation of infected erythrocytes was developed at the Queensland Institute of Medical Research (QIMR) more than 15 years ago. Since that time, this system has been used in several studies to investigate the protective effect of vaccines, the clearance kinetics of parasites following drug treatment, and to improve understanding of the early events in blood stage infection. In this article, we will review the development of IBSM and the applications for which it is being employed...
November 2012: Trends in Parasitology
https://www.readbyqxmd.com/read/22644646/internet-based-self-management-compared-with-usual-care-in-adolescents-with-asthma-a-randomized-controlled-trial
#13
RANDOMIZED CONTROLLED TRIAL
E R V M Rikkers-Mutsaerts, A E Winters, M J Bakker, H F van Stel, V van der Meer, J C de Jongste, J K Sont
INTRODUCTION: Asthma control often is poor in adolescents and this causes considerable morbidity. Internet-based self-management (IBSM) improves asthma-related quality of life in adults. We hypothesized that IBSM improves asthma-related quality of life in adolescents. METHODS: Adolescents (12-18 years) with persistent and not well-controlled asthma participated in a randomized controlled trial with 1 year follow-up and were allocated to IBSM (n = 46) or usual care (UC, n = 44)...
December 2012: Pediatric Pulmonology
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