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- 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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| 5. |
- Karadenizli, A., et al.
(författare)
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Genomic analyses of Francisella tularensis strains confirm disease transmission from drinking water sources, Turkey, 2008, 2009 and 2012
- 2015
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Ingår i: Eurosurveillance. - 1025-496X .- 1560-7917. ; 20:21
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Tidskriftsartikel (refereegranskat)abstract
- Waterborne epidemics of tularaemia caused by Francisella tularensis are increasingly reported in Turkey. We have used whole genome sequencing to investigate if F. tularensis isolated from patients could be traced back to drinking water sources. Tonsil swabs from 33 patients diagnosed with oropharyngeal tularaemia in three outbreaks and 140 water specimens were analysed. F. tularensis subsp. holarctica was confirmed by microagglutination and PCR in 12 patients and five water specimens. Genomic analysis of three pairs of patient and water isolates from outbreaks in Sivas, Corum, and Kocaeli showed the isolates to belong to two new clusters of the F. tularensis B. 12 genetic clade. The clusters were defined by 19 and 15 single nucleotide polymorphisms (SNPs) in a multiple alignment based on 507 F. tularensis genomes. One synonymous SNP was chosen as a new canonical SNP (canSNP) for each cluster for future use in diagnostic assays. No SNP was identified between the genomes from the patient-water pair of isolates from Kocaeli, one SNP between the pair of isolates from Sivas, whereas the pair from Corum differed at seven SNPs. These results illustrate the power of whole genome sequencing for tracing F. tularensis patient isolates back to their environmental source.
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| 6. |
- Afset, J. E., et al.
(författare)
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Phylogeographical pattern of Francisella tularensis in a nationwide outbreak of tularaemia in Norway, 2011
- 2015
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Ingår i: Eurosurveillance. - 1025-496X .- 1560-7917. ; 20:19, s. 9-14
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Tidskriftsartikel (refereegranskat)abstract
- In 2011, a nationwide outbreak of tularaemia occurred in Norway with 180 recorded cases. It was associated with the largest peak in lemming density seen in 40 years. Francisella tularensis was isolated from 18 patients. To study the geographical distribution of F. tularensis genotypes in Norway and correlate genotype with epidemiology and clinical presentation, we performed whole genome sequencing of patient isolates. All 18 genomes from the outbreak carried genetic signatures of F. tularensis subsp. holarctica and were assigned to genetic clades using canonical single nucleotide polymorphisms. Ten isolates were assigned to major genetic clade B.6 (subclade B.7), seven to clade B.12, and one to clade B.4. The B.6 subclade B.7 was most common in southern and central Norway, while clade B.12 was evenly distributed between the southern, central and northern parts of the country. There was no association between genotype and clinical presentation of tularaemia, time of year or specimen type. We found extensive sequence similarity with F. tularensis subsp. holarctica genomes from high-endemic tularaemia areas in Sweden. Finding nearly identical genomes across large geographical distances in Norway and Sweden imply a life cycle of the bacterium without replication between the outbreaks and raise new questions about long-range migration mechanisms.
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- Flannagan, Carol. A. C., et al.
(författare)
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Comparing motor-vehicle crash risk of EU and US vehicles
- 2018
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Ingår i: Accident Analysis and Prevention. - : Elsevier. - 0001-4575 .- 1879-2057. ; 117, s. 392-397
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Tidskriftsartikel (refereegranskat)abstract
- This study examined the hypotheses that passenger vehicles meeting European Union (EU) safety standards have similar crashworthiness to United States (US) -regulated vehicles in the US driving environment, and vice versa. The first step involved identifying appropriate databases of US and EU crashes that include in-depth crash information, such as estimation of crash severity using Delta-V and injury outcome based on medical records. The next step was to harmonize variable definitions and sampling criteria so that the EU data could be combined and compared to the US data using the same or equivalent parameters. Logistic regression models of the risk of a Maximum injury according to the Abbreviated Injury Scale of 3 or greater, or fatality (MAIS3+F) in EU-regulated and US-regulated vehicles were constructed. The injury risk predictions of the EU model and the US model were each applied to both the US and EU standard crash populations. Frontal, near-side, and far-side crashes were analyzed together (termed "front/side crashes") and a separate model was developed for rollover crashes.For the front/side model applied to the US standard population, the mean estimated risk for the US-vehicle model is 0.035 (sd = 0.012), and the mean estimated risk for the EU-vehicle model is 0.023 (sd = 0.016). When applied to the EU front/side population, the US model predicted a 0.065 risk (sd = 0.027), and the EU model predicted a 0.052 risk (sd = 0.025). For the rollover model applied to the US standard population, the US model predicted a risk of 0.071 (sd = 0.024), and the EU model predicted 0.128 risk (sd = 0.057). When applied to the EU rollover standard population, the US model predicted a 0.067 risk (sd = 0.024), and the EU model predicted 0.103 risk (sd = 0.040).The results based on these methods indicate that EU vehicles most likely have a lower risk of MAIS3+F injury in front/side impacts, while US vehicles most likely have a lower risk of MAIS3+F injury in llroovers. These results should be interpreted with an understanding of the uncertainty of the estimates, the study limitations, and our recommendations for further study detailed in the report.
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