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| 2. |
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| 3. |
- Singh, K. P., et al.
(författare)
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Clinical standards for the management of adverse effects during treatment for TB
- 2023
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Ingår i: The International Journal of Tuberculosis and Lung Disease. - : International Union Against Tuberculosis and Lung Disease. - 1027-3719 .- 1815-7920. ; 27:7, s. 506-519
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE.METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards.RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.
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| 4. |
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| 5. |
- Alffenaar, J. W. C., et al.
(författare)
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Clinical standards for the dosing and management of TB drugs
- 2022
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Ingår i: The International Journal of Tuberculosis and Lung Disease. - Paris, France : International Union Against Tuberculosis and Lung Disease. - 1027-3719 .- 1815-7920. ; 26:6, s. 483-
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on 'best practice' for dosing and management of TB drugs.Methods: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants.Results: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified.Conclusion: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.
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| 6. |
- Borisov, S, et al.
(författare)
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
- 2019
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Ingår i: The European respiratory journal. - : European Respiratory Society (ERS). - 1399-3003 .- 0903-1936. ; 54:6
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Tidskriftsartikel (refereegranskat)abstract
- The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
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| 8. |
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| 9. |
- Crona, Joakim, et al.
(författare)
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ENSAT registry-based randomized clinical trials for adrenocortical carcinoma
- 2021
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Ingår i: European Journal of Endocrinology. - : Bioscientifica. - 0804-4643 .- 1479-683X. ; 184:2, s. R51-R59
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Forskningsöversikt (refereegranskat)abstract
- Adrenocortical carcinoma (ACC) is an orphan disease lacking effective systemic treatment options. The low incidence of the disease and high cost of clinical trials are major obstacles in the search for improved treatment strategies. As a novel approach, registry-based clinical trials have been introduced in clinical research, so allowing for significant cost reduction, but without compromising scientific benefit. Herein, we describe how the European Network for the Study of Adrenal Tumours (ENSAT) could transform its current registry into one fit for a clinical trial infrastructure. The rationale to perform randomized registry-based trials in ACC is outlined including an analysis of relevant limitations and challenges. We summarize a survey on this concept among ENSAT members who expressed a strong interest in the concept and rated its scientific potential as high. Legal aspects, including ethical approval of registry-based randomization were identified as potential obstacles. Finally, we describe three potential randomized registry-based clinical trials in an adjuvant setting and for advanced disease with a high potential to be executed within the framework of an advanced ENSAT registry. Thus we, therefore, provide the basis for future registry-based trials for ACC patients. This could ultimately provide proof-of-principle of how to perform more effective randomized trials for an orphan disease.
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| 10. |
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| 11. |
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| 12. |
- Ardura-Fabregat, A., et al.
(författare)
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Targeting Neuroinflammation to Treat Alzheimer’s Disease
- 2017
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Ingår i: CNS Drugs. - : Springer Science and Business Media LLC. - 1172-7047 .- 1179-1934. ; 31:12, s. 1-26
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Forskningsöversikt (refereegranskat)abstract
- Over the past few decades, research on Alzheimer’s disease (AD) has focused on pathomechanisms linked to two of the major pathological hallmarks of extracellular deposition of beta-amyloid peptides and intra-neuronal formation of neurofibrils. Recently, a third disease component, the neuroinflammatory reaction mediated by cerebral innate immune cells, has entered the spotlight, prompted by findings from genetic, pre-clinical, and clinical studies. Various proteins that arise during neurodegeneration, including beta-amyloid, tau, heat shock proteins, and chromogranin, among others, act as danger-associated molecular patterns, that—upon engagement of pattern recognition receptors—induce inflammatory signaling pathways and ultimately lead to the production and release of immune mediators. These may have beneficial effects but ultimately compromise neuronal function and cause cell death. The current review, assembled by participants of the Chiclana Summer School on Neuroinflammation 2016, provides an overview of our current understanding of AD-related immune processes. We describe the principal cellular and molecular players in inflammation as they pertain to AD, examine modifying factors, and discuss potential future therapeutic targets.
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| 13. |
- Lange, C., et al.
(författare)
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Management of patients with multidrug-resistant tuberculosis
- 2019
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Ingår i: The International Journal of Tuberculosis and Lung Disease. - : INT UNION AGAINST TUBERCULOSIS LUNG DISEASE (I U A T L D). - 1027-3719 .- 1815-7920. ; 23:6, s. 645-662
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Tidskriftsartikel (refereegranskat)abstract
- The emergence of multidrug-resistant tuberculosis (MDR-TB; defined as resistance to at least rifampicin and isoniazid) represents a growing threat to public health and economic growth. Never before in the history of mankind have more patients been affected by MDR-TB than is the case today. The World Health Organization reports that MDR-TB outcomes are poor despite staggeringly high management costs. Moreover, treatment is prolonged, adverse events are common, and the majority of affected patients do not receive adequate treatment. As MDR-TB strains are often resistant to one or more second-line anti-TB drugs, in-depth genotypic and phenotypic drug susceptibility testing is needed to construct personalised treatment regimens to improve treatment outcomes. For the first time in decades, the availability of novel drugs such as bedaquiline allow us to design potent and well-tolerated personalised MDR-TB treatment regimens based solely on oral drugs. In this article, we present management guidance to optimise the diagnosis, algorithm-based treatment, drug dosing and therapeutic drug monitoring, and the management of adverse events and comorbidities, associated with MDR-TB. We also discuss the role of surgery, physiotherapy, rehabilitation, palliative care and smoking cessation in patients with MDR-TB. We hope that incorporating these recommendations into patient care will be helpful in optimising treatment outcomes, and lead to more MDR-TB patients achieving a relapse-free cure.
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| 14. |
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| 15. |
- du Cros, P, et al.
(författare)
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Standards for clinical trials for treating TB
- 2023
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Ingår i: The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease. - 1815-7920. ; 27:12, s. 885-898
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Tidskriftsartikel (refereegranskat)
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| 16. |
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| 17. |
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| 18. |
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| 19. |
- Plasman, M., et al.
(författare)
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Lithospheric low-velocity zones associated with a magmatic segment of the Tanzanian Rift, East Africa
- 2017
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Ingår i: Geophysical Journal International. - : OXFORD UNIV PRESS. - 0956-540X .- 1365-246X. ; 210:1, s. 465-481
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Tidskriftsartikel (refereegranskat)abstract
- Rifting in a cratonic lithosphere is strongly controlled by several interacting processes including crust/mantle rheology, magmatism, inherited structure and stress regime. In order to better understand how these physical parameters interact, a 2 yr long seismological experiment has been carried out in the North Tanzanian Divergence (NTD), at the southern tip of the eastern magmatic branch of the East African rift, where the southward-propagating continental rift is at its earliest stage. We analyse teleseismic data from 38 broad-band stations ca. 25 km spaced and present here results from their receiver function (RF) analysis. The crustal thickness and Vp/Vs ratio are retrieved over a ca. 200 x 200 km(2) area encompassing the South Kenya magmatic rift, the NTD and the Ngorongoro-Kilimanjaro transverse volcanic chain. Cratonic nature of the lithosphere is clearly evinced through thick (up to ca. 40 km) homogeneous crust beneath the rift shoulders. Where rifting is present, Moho rises up to 27 km depth and the crust is strongly layered with clear velocity contrasts in the RF signal. The Vp/Vs ratio reaches its highest values (ca. 1.9) beneath volcanic edifices location and thinner crust, advocating for melting within the crust. We also clearly identify two major low-velocity zones (LVZs) within the NTD, one in the lower crust and the second in the upper part of the mantle. The first one starts at 15-18 km depth and correlates well with recent tomographic models. This LVZ does not always coexist with high Vp/Vs ratio, pleading for a supplementary source of velocity decrease, such as temperature or composition. At a greater depth of ca. 60 km, a midlithospheric discontinuity roughly mimics the step-like and symmetrically outward-dipping geometry of the Moho butwith a more slanting direction (NE-SW) compared to theNS rift. By comparison with synthetic RF, we estimate the associated velocity reduction to be 8-9 per cent. We relate this interface to melt ponding, possibly favouring here deformation process such as grain-boundary sliding (EAGBS) due to lithospheric strain. Its geometry might have been controlled by inherited lithospheric fabrics and heterogeneous upper mantle structure. We evidence that crustal and mantle magmatic processes represent first order mechanisms to ease and locate the deformation during the first stage of a cratonic lithospheric breakup.
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| 20. |
- Tiberi, C., et al.
(författare)
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Lithospheric modification by extension and magmatism at the craton-orogenic boundary : North Tanzania Divergence, East Africa
- 2019
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Ingår i: Geophysical Journal International. - : OXFORD UNIV PRESS. - 0956-540X .- 1365-246X. ; 216:3, s. 1693-1710
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Tidskriftsartikel (refereegranskat)abstract
- We present a joint analysis of newly acquired gravity and teleseismic data in the North Tanzanian Divergence, where the lithospheric break-up is at its earliest stage. The impact of a mantle upwelling in more mature branches of the East African Rift has been extensively studied at a lithospheric scale. However, few studies have been completed that relate the deep-seated mantle anomaly detected in broad regional seismic tomography with the surface deformation observed in the thick Archaean Pan-African suture zone located in North Tanzania. Our joint inversion closes the gap between local and regional geophysical studies, providing velocity and density structures from the surface down to ca. 250 km depth with new details. Our results support the idea of a broad mantle upwelling rising up to the lithosphere and creating a thermal modification along its path. However, our study clearly presents an increasing amplitude of the associated anomaly both in velocity and density above 200 km depth, which cannot be solely explained by a temperature rise. We infer from our images the combined impact of melt (2-3 per cent), composition and hydration that accompany the modification of a thick heterogenous cratonic lithosphere are a response to the hot mantle rising. The detailed images we obtained in density and velocity assert that Archaean and Proterozoic units interact with the mantle upwelling to restrict the lithosphere modifications within the Magadi-Natron-Manyara rift arm. The composition and hydration variations associated with those units equilibrate the thermal erosion of the craton root and allow for its stability between 100 and 200 km depth. Above 80 km depth, the crustal part is strongly affected by intruding bodies (melt and gas) which produces large negative anomalies in both velocity and density beneath the main magmatic centres. In addition to the global impact of a superplume, the velocity and density anomaly pattern suggests a 3-D distribution of the crust and mantle lithospheric stretching, which is likely to be controlled by inherited fabrics and enhanced by lateral compositional and hydration variations at the Tanzanian craton-orogenic belt boundary.
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| 21. |
- Amundin, Mats, et al.
(författare)
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Estimating the abundance of the critically endangered Baltic Proper harbour porpoise (Phocoena phocoena) population using passive acoustic monitoring
- 2022
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Ingår i: Ecology and Evolution. - : Wiley. - 2045-7758. ; 12:2
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Tidskriftsartikel (refereegranskat)abstract
- Knowing the abundance of a population is a crucial component to assess its conservationstatus and develop effective conservation plans. For most cetaceans, abundanceestimation is difficult given their cryptic and mobile nature, especially when thepopulation is small and has a transnational distribution. In the Baltic Sea, the numberof harbour porpoises (Phocoena phocoena) has collapsed since the mid-20thcenturyand the Baltic Proper harbour porpoise is listed as Critically Endangered by the IUCNand HELCOM; however, its abundance remains unknown. Here, one of the largestever passive acoustic monitoring studies was carried out by eight Baltic Sea nationsto estimate the abundance of the Baltic Proper harbour porpoise for the first time. Bylogging porpoise echolocation signals at 298 stations during May 2011–April2013,calibrating the loggers’ spatial detection performance at sea, and measuring the clickrate of tagged individuals, we estimated an abundance of 71–1105individuals (95% CI,point estimate 491) during May–Octoberwithin the population's proposed managementborder. The small abundance estimate strongly supports that the Baltic Properharbour porpoise is facing an extremely high risk of extinction, and highlights theneed for immediate and efficient conservation actions through international cooperation.It also provides a starting point in monitoring the trend of the populationabundance to evaluate the effectiveness of management measures and determine itsinteractions with the larger neighboring Belt Sea population. Further, we offer evidencethat design-basedpassive acoustic monitoring can generate reliable estimatesof the abundance of rare and cryptic animal populations across large spatial scales.
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| 22. |
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| 23. |
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| 24. |
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| 25. |
- Di Benedetto, M. D., et al.
(författare)
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Networked control
- 2009
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Ingår i: Handbook of Hybrid Systems Control. - : Cambridge University Press. - 9780521765053
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Bokkapitel (refereegranskat)
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| 26. |
- Di Benedetto, M. D., et al.
(författare)
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Wireless ventilation control for large-scale systems : The mining industrial case
- 2009
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Ingår i: 2009 6th IEEE Annual Communications Society Conference on Sensor, Mesh and Ad Hoc Communications and Networks Workshops. - 9781424439386
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Konferensbidrag (refereegranskat)abstract
- Mining ventilation is an interesting example of a large scale system with high environmental impact where advanced control strategies can bring major improvements. Indeed, one of the first objectives of modern mining industry is to fulfill environmental specifications [1] during the ore extraction and crushing, by optimizing the energy consumption or the production of polluting agents. The mine electric consumption was 4 % of total industrial electric demand in the US in 1994 (6 % in 2007 in South Africa) and 90 % of it was related to motor system energy [2]. Another interesting figure is given in [3] where it is estimated that the savings associated with global control strategies for fluid systems (pumps, fans and compressors) represent approximately 20 % of the total manufacturing motor system energy savings. This motivates the development of new control strategies for large scale aerodynamic processes based on appropriate automation and a global consideration of the system. More specifically, the challenge in this work is focused on the mining ventilation since as much as 50 % or more of the energy consumed by the mining process may go into the ventilation (including heating the air). It is clear that investigating automatic control solutions and minimizing the amount of pumped air to save energy consumption (proportional to the cube of airflow quantity [4]) is of great environmental and industrial interest.
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| 27. |
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| 28. |
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| 29. |
- Gunther, G, et al.
(författare)
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Beyond multidrug-resistant tuberculosis in Europe: a TBNET study
- 2015
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Ingår i: The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease. - : International Union Against Tuberculosis and Lung Disease. - 1815-7920. ; 19:12, s. 1524-1527
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Tidskriftsartikel (refereegranskat)
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| 30. |
- McClenaghan, C, et al.
(författare)
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Sulfonylurea-Insensitive Permanent Neonatal Diabetes Caused by a Severe Gain-of-Function Tyr330His Substitution in Kir6.2
- 2022
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Ingår i: Hormone research in paediatrics. - : S. Karger AG. - 1663-2826 .- 1663-2818. ; 95:3, s. 215-223
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Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background/Aims:</i></b> Mutations in <i>KCNJ11</i>, the gene encoding the Kir6.2 subunit of pancreatic and neuronal K<sub>ATP</sub> channels, are associated with a spectrum of neonatal diabetes diseases. <b><i>Methods:</i></b> Variant screening was used to identify the cause of neonatal diabetes, and continuous glucose monitoring was used to assess effectiveness of sulfonylurea treatment. Electrophysiological analysis of variant K<sub>ATP</sub> channel function was used to determine molecular basis. <b><i>Results:</i></b> We identified a previously uncharacterized <i>KCNJ11</i> mutation, c.988T>C [p.Tyr330His], in an Italian child diagnosed with sulfonylurea-resistant permanent neonatal diabetes and developmental delay (intermediate DEND). Functional analysis of recombinant K<sub>ATP</sub> channels reveals that this mutation causes a drastic gain-of-function, due to a reduction in ATP inhibition. Further, we demonstrate that the Tyr330His substitution causes a significant decrease in sensitivity to the sulfonylurea, glibenclamide. <b><i>Conclusions:</i></b> In this subject, the <i>KCNJ11</i> (c.988T>C) mutation provoked neonatal diabetes, with mild developmental delay, which was insensitive to correction by sulfonylurea therapy. This is explained by the molecular loss of sulfonylurea sensitivity conferred by the Tyr330His substitution and highlights the need for molecular analysis of such mutations.
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| 31. |
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| 32. |
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| 33. |
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| 34. |
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| 35. |
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| 36. |
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| 37. |
- Tiberi, Ubaldo, et al.
(författare)
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Adaptive self-triggered control over IEEE 802.15.4 networks
- 2010
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Konferensbidrag (refereegranskat)abstract
- The communication protocol IEEE 802.15.4 is becoming pervasive for low power and low data rate wireless sensor networks (WSNs) applications, including control and automation. Nevertheless, there is not yet any adequate study about control systems networked by this protocol. In this paper, the stability of IEEE 802.15.4 networked control systems (NCSs) is addressed. While in recent works fundamental results are developed for networks that are abstracted only in terms of packet loss and time delays, here the constraints imposed by the protocol to the feedback channel and the network energy consumption are explicitly considered. A general analysis for linear systems with parameter uncertainty and external bounded disturbances with control loops closed over IEEE 802.15.4 networks is proposed. To reduce the number of transmissions and thus save energy, a self-triggered control strategy is used. A sufficient stability condition is given as function of both the protocol and control parameters. A decentralized algorithm to adapt jointly the self-triggered control and the protocol parameters is proposed. It is concluded that stability is not always guaranteed unless protocol parameters are appropriately tuned, and that event-triggered control strategies may be difficult to use with the current version of IEEE 802.15.4.
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| 38. |
- Tiberi, Ubaldo, et al.
(författare)
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Energy-efficient sampling of networked control systems over IEEE 802.15.4 wireless networks
- 2013
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Ingår i: Automatica. - : Elsevier. - 0005-1098 .- 1873-2836. ; 49:3, s. 712-724
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Tidskriftsartikel (refereegranskat)abstract
- Self-triggered sampling is an attractive paradigm for closed-loop control over energy-constrained wireless sensor networks (WSNs) because it may give substantial communication savings. The understanding of the performance of self-triggered control systems when the feedback loops are closed over IEEE 802.15.4 WSNs is of major interest, since the communication standard IEEE 802.15.4 is the de-facto reference protocol for energy-efficient WSNs. In this paper, a new approach to control several processes over a shared IEEE 802.15.4 network by self-triggered sampling is proposed. It is shown that the sampling time of the processes, the protocol parameters, and the scheduling of the transmissions must be jointly selected to achieve a good performance of the closed-loop system and an energy-efficient utilization of the network. The challenging part of the proposed analysis is ensuring globally uniformly ultimately boundedness of the controlled processes while providing efficient scheduling of the process state transmissions. Such a scheduling is difficult when asynchronous multiple control loops share the network, because transmissions over IEEE 802.15.4 are allowed only at certain time slots. The proposed approach establishes that the joint design of self-triggered samplers and the network protocol (1) ensures globally uniformly ultimately boundedness of each control loop, (2) reduces the number of sensor transmissions, and (3) increases the sleep time of the transmitting nodes. A new dynamic scheduling problem is proposed for the joint control of each process and network protocol adaptation. An algorithm is derived, which adapts the network parameters according to the self-triggered sampler of every control loop. Numerical examples illustrate the analysis and show the benefits of the approach. It is concluded that self-triggered control strategies over WSNs ensure desired control performance, reduce the network utilization, and reduce energy consumption only if the protocol parameters are appropriately regulated.
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| 39. |
- Tiberi, U., et al.
(författare)
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Self-triggered control of multiple loops over IEEE 802.15.4 networks
- 2011
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Ingår i: IFAC Proceedings Volumes. - 9783902661937 ; , s. 13893-13898
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Konferensbidrag (refereegranskat)abstract
- Given the communication savings offered by self-triggered sampling, it is becoming an essential paradigm for closed-loop control over energy-constrained wireless sensor networks (WSNs). The understanding of the performance of self-triggered control systems when the feedback loops are closed over IEEE 802.15.4 WSNs is of major interest, since the communication standard IEEE 802.15.4 is the de-facto the reference protocol for energy-efficient WSNs. In this paper, a new approach to control several processes over a shared IEEE 802.15.4 network by self-triggered sampling is proposed. It is shown that the sampling time of the processes, the protocol parameters, and the scheduling of the transmissions must be jointly selected to ensure stability of the processes and energy efficiency of the network. The challenging part of the proposed analysis is ensuring stability and making an energy efficient scheduling of the state transmissions. These transmissions over IEEE 802.15.4 are allowed only at certain time slots, which are difficult to schedule when multiple control loops share the network. The approach establishes that the joint design of self-triggered samplers and the network protocol 1) ensures the stability of each loop, 2) increases the network capacity, 3) reduces the number of transmissions of the nodes, and 4) increases the sleep time of the nodes. A new dynamic scheduling problem is proposed to control each process, adapt the protocol parameters, and reduce the energy consumption. An algorithm is then derived, which adapts to any choice of the self-triggered samplers of every control loop. Numerical examples illustrate the analysis and show the benefits of the new approach.
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| 40. |
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| 41. |
- van den Elsen, SHJ, et al.
(författare)
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Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT): a study protocol of a prospective multicentre cohort study
- 2020
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 10:6, s. e035350-
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Tidskriftsartikel (refereegranskat)abstract
- Global multidrug-resistant tuberculosis (MDR-TB) treatment success rates remain suboptimal. Highly active WHO group A drugs moxifloxacin and levofloxacin show intraindividual and interindividual pharmacokinetic variability which can cause low drug exposure. Therefore, therapeutic drug monitoring (TDM) of fluoroquinolones is recommended to personalise the drug dosage, aiming to prevent the development of drug resistance and optimise treatment. However, TDM is considered laborious and expensive, and the clinical benefit in MDR-TB has not been extensively studied. This observational multicentre study aims to determine the feasibility of centralised TDM and to investigate the impact of fluoroquinolone TDM on sputum conversion rates in patients with MDR-TB compared with historical controls.Methods and analysisPatients aged 18 years or older with sputum smear and culture-positive pulmonary MDR-TB will be eligible for inclusion. Patients receiving TDM using a limited sampling strategy (t=0 and t=5 hours) will be matched to historical controls without TDM in a 1:2 ratio. Sample analysis and dosing advice will be performed in a centralised laboratory. Centralised TDM will be considered feasible if >80% of the dosing recommendations are returned within 7 days after sampling and 100% within 14 days. The number of patients who are sputum smear and culture-negative after 2 months of treatment will be determined in the prospective TDM group and will be compared with the control group without TDM to determine the impact of TDM.Ethics and disseminationEthical clearance was obtained by the ethical review committees of the 10 participating hospitals according to local procedures or is pending (online supplementary file 1). Patients will be included after obtaining written informed consent. We aim to publish the study results in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT03409315).
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| 42. |
- Witrant, E., et al.
(författare)
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Wireless ventilation control for large-scale systems : The mining industrial case
- 2010
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Ingår i: International Journal of Robust and Nonlinear Control. - : Wiley. - 1049-8923 .- 1099-1239. ; 20:2, s. 226-251
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Tidskriftsartikel (refereegranskat)abstract
- This paper describes a new industrial case on automation, for large-scale systems with high environmental impact: the mining ventilation control systems. Ventilation control is essential for the operation of a mine in terms of safety (CO and NO, regulation) and energy optimization. We first discuss a novel regulation architecture, highlighting the interest for a model-based control approach and the use of distributed sensing capabilities thanks to a wireless sensor network (WSN). We propose a new model for underground ventilation. The main components of the system dynamics are described with time-delays, transmission errors, energy losses and concentration profiles. Two different model-based control approaches, which can embody the complex dynamics of the system, are proposed. The first one resorts to a nonlinear model predictive control strategy (receding horizon) and aims to energy minimization, thanks to a continuous operation of the fans. The second one, based on a hybrid description of the model and fans operation, provides automatic verification of the wireless control thanks to abstraction techniques. These control strategies are compared with simulations, in terms of regulation efficiency, energy consumption and the need for computational capabilities. The industrial case description and control strategies open new vistas for the development of global system approaches that allow for the optimization of energy consumption of complex large-scale systems.
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