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Article ; Online: In vitro activity of cefiderocol against Gram-negative pathogens isolated from people with cystic fibrosis and bronchiectasis.

Tunney, Michael M / Elborn, J Stuart / McLaughlin, Chloe S / Longshaw, Christopher M

Journal of global antimicrobial resistance

2024 Volume 36, Page(s) 407–410

Abstract: Objectives: Gram-negative pathogens causing respiratory infection in people with cystic fibrosis and bronchiectasis are becoming progressively more resistant to conventional antibiotics. Although cefiderocol is licenced for the treatment of infections ... ...

Abstract	Objectives: Gram-negative pathogens causing respiratory infection in people with cystic fibrosis and bronchiectasis are becoming progressively more resistant to conventional antibiotics. Although cefiderocol is licenced for the treatment of infections due to Gram-negative organisms, there are limited data on the activity of cefiderocol against pathogens associated with chronic respiratory diseases. The aim of this study was to determine the susceptibility of Gram-negative pathogens from cystic fibrosis and bronchiectasis to cefiderocol and comparator antibiotics. Methods: Minimal inhibitory concentrations (MICs) of cefiderocol and 15 comparator antibiotics were determined by broth microdilution against 300 respiratory isolates: Burkholderia spp., Stenotrophomonas spp., Achromobacter spp., Ralstonia spp. and Pandoraea spp., and used to calculate the MIC of each antibiotic required to inhibit 50% (MIC Results: The MIC Conclusions: These in vitro data demonstrated that cefiderocol had greater activity than most comparator antibiotics and could be an alternative treatment option for respiratory infection caused by these pathogens that has not responded to first-line therapy.
MeSH term(s)	Humans ; Cefiderocol ; Cephalosporins/pharmacology ; Cystic Fibrosis/complications ; Gram-Negative Bacteria ; Drug Resistance, Multiple, Bacterial ; Anti-Bacterial Agents/pharmacology ; Bronchiectasis ; Respiratory Tract Infections
Chemical Substances	Cefiderocol (SZ34OMG6E8) ; Cephalosporins ; Anti-Bacterial Agents
Language	English
Publishing date	2024-02-07
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2710046-7
ISSN	2213-7173 ; 2213-7173
ISSN (online)	2213-7173
ISSN	2213-7173
DOI	10.1016/j.jgar.2024.01.023
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Article ; Online: A discrete choice experiment to quantify the influence of trial features on the decision to participate in cystic fibrosis trials.

Dobra, Rebecca / Davies, Jane / Elborn, Stuart / Kee, Frank / Madge, Susan / Boeri, Marco

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

2023 Volume 23, Issue 1, Page(s) 73–79

Abstract: Background: Patient-centred trial design optimises recruitment and retention, reduces trial failure rates and increases the diversity of trial cohorts. This allows safe and effective treatments to reach clinic more quickly. To achieve this, patients' ... ...

Abstract	Background: Patient-centred trial design optimises recruitment and retention, reduces trial failure rates and increases the diversity of trial cohorts. This allows safe and effective treatments to reach clinic more quickly. To achieve this, patients' views must be incorporated into trial design. Methods: A discrete choice experiment was used to quantify preferences of pwCF for trials features; medicine type, trial location, stipend, washout, drug access on trial completion and trial design. Respondents were presented pairs of hypothetical trial scenarios with different level combinations assigned through experimental design. Respondents were asked to pick their preferred option or decline both. The cross-sectional data were explored using a Random Parameters Logit model. Results: We received 207 eligible responses between Oct2020-Jan2021. The strongest influence on the decision to participate was trial location; pwCF favour participation at their usual clinical centre. Greater travel distances made respondents less willing to participate. Post-trial drug access ranked second. pwCF would rather participate in modulator trials than trials of other drugs. In general, pwCF did not favour a washout period, but were more prepared to washout non-modulators than modulators. Stipend provision was not ranked highly, but higher stipends increased intention to participate. Trial design (placebo vs open-label) had minimal influence on the decision to participate. There are complex interactions between placebos and washouts. Conclusions: We used quantitative methods to systematically elicit preferences of pwCF for clinical trials' features. We explore the relevance of our findings to trial design and delivery in the current CF trials landscape.
MeSH term(s)	Humans ; Cystic Fibrosis/drug therapy ; Cross-Sectional Studies ; Research Design
Language	English
Publishing date	2023-12-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2084724-5
ISSN	1873-5010 ; 1569-1993
ISSN (online)	1873-5010
ISSN	1569-1993
DOI	10.1016/j.jcf.2023.04.024
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Article ; Online: Infection with Prevotella nigrescens induces TLR2 signalling and low levels of p65 mediated inflammation in Cystic Fibrosis bronchial epithelial cells.

Bertelsen, A / Elborn, J S / Schock, B C

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

2019 Volume 19, Issue 2, Page(s) 211–218

Abstract: Prevotella spp. are frequently identified in Cystic Fibrosis sputum. This study examined whether infection with Prevotella nigrescens, a frequently identified member of this species, contributes to inflammation in CF bronchial epithelial cells through ... ...

Abstract	Prevotella spp. are frequently identified in Cystic Fibrosis sputum. This study examined whether infection with Prevotella nigrescens, a frequently identified member of this species, contributes to inflammation in CF bronchial epithelial cells through activation of TLR- and NF-κB signalling pathways. CFBE41o- cells were infected with either P.nigrescens or Pseudomonas aeruginosa and incubated under anaerobic conditions for 4h. P.nigrescens activated TLR2 signalling but not TLR4 signalling while P.aeruginosa activated TLR4 signalling with a lesser effect on TLR2. P.aeruginosa induced significant IκBα phosphorylation 10min post infection with a return to control levels by 30min post infection. A significant induction in nuclear p65 DNA binding was observed at 2h post infection. In contrast, infection with P.nigrescens induced phosphorylation of IκBα 120min post infection, with significant induction in nuclear p65 DNA binding at 4h post infection only. Cytokine gene and protein responses were lower for P.nigrescens compared to P.aeruginosa. This study demonstrates the ability of a clinical P.nigrescens isolate to provoke a delayed NF-κB(p65) driven response through induction in TLR2 signalling and activation of sustained levels of IKKα.
MeSH term(s)	Bacteria, Anaerobic ; Cells, Cultured ; Cystic Fibrosis/immunology ; Cystic Fibrosis/microbiology ; Host-Pathogen Interactions ; Humans ; Inflammation/metabolism ; NF-kappa B/metabolism ; Prevotella nigrescens/physiology ; Pseudomonas aeruginosa/physiology ; Respiratory Mucosa/immunology ; Respiratory Mucosa/metabolism ; Signal Transduction ; Toll-Like Receptor 2/metabolism ; Toll-Like Receptor 4/metabolism ; Transcription Factor RelA/metabolism
Chemical Substances	NF-kappa B ; TLR4 protein, human ; Toll-Like Receptor 2 ; Toll-Like Receptor 4 ; Transcription Factor RelA
Language	English
Publishing date	2019-10-10
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2084724-5
ISSN	1873-5010 ; 1569-1993
ISSN (online)	1873-5010
ISSN	1569-1993
DOI	10.1016/j.jcf.2019.09.005
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Article: A systematic review to identify and collate factors influencing patient journeys through clinical trials.

Dobra, Rebecca / Wilson, Gemma / Matthews, Jessie / Boeri, Marco / Elborn, Stuart / Kee, Frank / Davies, Jane C / Madge, Susan

JRSM open

2023 Volume 14, Issue 6, Page(s) 20542704231166621

Abstract: Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area ... ...

Abstract	Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.
Language	English
Publishing date	2023-06-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2762955-7
ISSN	2054-2704
ISSN	2054-2704
DOI	10.1177/20542704231166621
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Article ; Online: Sputum trypsin-like protease activity relates to clinical outcome in cystic fibrosis.

Reihill, James / Moffitt, Kelly / Douglas, Lisa / Stuart Elborn, J / Jones, Andrew / Lorraine Martin, S

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

2020 Volume 19, Issue 4, Page(s) 647–653

Abstract: Background: In cystic fibrosis (CF) airways excessive levels of serine trypsin-like proteases (TLPs) activate the epithelial sodium channel (ENaC) resulting in airways dehydration and promotion of mucus secretion. Despite this the relationship of TLP ... ...

Abstract	Background: In cystic fibrosis (CF) airways excessive levels of serine trypsin-like proteases (TLPs) activate the epithelial sodium channel (ENaC) resulting in airways dehydration and promotion of mucus secretion. Despite this the relationship of TLP activity and clinical outcome has not been studied. Methods: We analysed supernatant (sol) prepared from CF sputum from adult CF patients in two study cohorts (29 and 33 samples, respectively). Protease activities were determined by measuring the hydrolysis of peptide-based substrates or by ELISA. Lung function was assessed by spirometry (FEV Results: TLP activity inversely correlated with percent predicted FEV Conclusions: Sputum TLP activity may represent a novel non-invasive biomarker and/or therapeutic target for CF lung disease.
MeSH term(s)	Adult ; Biomarkers/metabolism ; Clinical Chemistry Tests/methods ; Cystic Fibrosis/metabolism ; Cystic Fibrosis/mortality ; Cystic Fibrosis/physiopathology ; Epithelial Sodium Channels/metabolism ; Female ; Humans ; Immunoenzyme Techniques/methods ; Ion Transport/physiology ; Male ; Reproducibility of Results ; Respiratory Function Tests/methods ; Respiratory Mucosa/metabolism ; Respiratory Mucosa/physiopathology ; Serine Endopeptidases/metabolism ; Sputum/metabolism ; Survival Analysis
Chemical Substances	Biomarkers ; Epithelial Sodium Channels ; trypsin-like serine protease ; Serine Endopeptidases (EC 3.4.21.-)
Language	English
Publishing date	2020-01-11
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2084724-5
ISSN	1873-5010 ; 1569-1993
ISSN (online)	1873-5010
ISSN	1569-1993
DOI	10.1016/j.jcf.2019.12.014
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Article: Analysis of SARS-CoV-2 antibody seroprevalence in Northern Ireland during 2020-2021.

Greene, Michelle K / Smyth, Peter / English, Andrew / McLaughlin, Joseph / Bucholc, Magda / Bailie, Janice / McCarroll, Julie / McDonnell, Margaret / Watt, Alison / Barnes, George / Lynch, Mark / Duffin, Kevan / Duffy, Gerard / Lewis, Claire / James, Jacqueline A / Stitt, Alan W / Ford, Tom / O'Kane, Maurice / Rai, Taranjit Singh /

Bjourson, Anthony J / Cardwell, Christopher / Elborn, J Stuart / Gibson, David S / Scott, Christopher J

Heliyon

2024 Volume 10, Issue 2, Page(s) e24184

Abstract: ... anti-SARS-CoV-2 or anti-SARS-CoV-2 S ECLIA (Roche) on an automated cobas e 801 analyser. Samples were ...

Abstract	Background: With the spread of SARS-CoV-2 impacting upon public health directly and socioeconomically, further information was required to inform policy decisions designed to limit virus spread during the pandemic. This study sought to contribute to serosurveillance work within Northern Ireland to track SARS-CoV-2 progression and guide health strategy. Methods: Sera/plasma samples from clinical biochemistry laboratories were analysed for anti-SARS-CoV-2 antibodies. Samples were assessed using an Elecsys anti-SARS-CoV-2 or anti-SARS-CoV-2 S ECLIA (Roche) on an automated cobas e 801 analyser. Samples were also assessed via an anti-SARS-CoV-2 ELISA (Euroimmun). A subset of samples assessed via the Elecsys anti-SARS-CoV-2 ECLIA were subsequently analysed in an ACE2 pseudoneutralisation assay using a V-PLEX SARS-CoV-2 Panel 7 for IgG and ACE2 (Meso Scale Diagnostics). Results: Across three testing rounds (June-July 2020, November-December 2020 and June-July 2021 (rounds 1-3 respectively)), 4844 residual sera/plasma specimens were assayed for anti-SARS-CoV-2 antibodies. Seropositivity rates increased across the study, peaking at 11.6 % (95 % CI 10.4 %-13.0 %) during round 3. Varying trends in SARS-CoV-2 seropositivity were noted based on demographic factors. For instance, highest rates of seropositivity shifted from older to younger demographics across the study period. In round 3, Alpha (B.1.1.7) variant neutralising antibodies were most frequently detected across age groups, with median concentration of anti-spike protein antibodies elevated in 50-69 year olds and anti-S1 RBD antibodies elevated in 70+ year olds, relative to other age groups. Conclusions: With seropositivity rates of <15 % across the assessment period, it can be concluded that the significant proportion of the Northern Ireland population had not yet naturally contracted the virus by mid-2021.
Language	English
Publishing date	2024-01-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2835763-2
ISSN	2405-8440
ISSN	2405-8440
DOI	10.1016/j.heliyon.2024.e24184
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Article ; Online: Omalizumab in Allergic Bronchopulmonary Aspergillosis: A Systematic Review and Meta-Analysis.

Jin, Meiling / Douglass, Jo A / Elborn, J Stuart / Agarwal, Ritesh / Calhoun, William J / Lazarewicz, Slawomir / Jaumont, Xavier / Yan, Meng

The journal of allergy and clinical immunology. In practice

2022 Volume 11, Issue 3, Page(s) 896–905

Abstract: Background: An unmet clinical need exists in the management of treatment-refractory allergic bronchopulmonary aspergillosis (ABPA). Omalizumab has shown promising effects in case series and cohort studies; however, evidence to support its routine ... ...

Abstract	Background: An unmet clinical need exists in the management of treatment-refractory allergic bronchopulmonary aspergillosis (ABPA). Omalizumab has shown promising effects in case series and cohort studies; however, evidence to support its routine clinical use is lacking. Objective: The aim of this systematic review and meta-analysis was to evaluate the clinical effectiveness and safety of omalizumab in patients with ABPA. Methods: We conducted a systematic search across standard databases using specific key words until May 13, 2021. We performed a meta-analysis to compare the effectiveness (exacerbations, oral corticosteroid [OCS] use, lung function, and patient-reported asthma control) and safety of pre- and post-omalizumab treatment. Subgroup analyses were performed for treatment duration and underlying disease. Results: In total, 49 studies (n = 267) were included in the qualitative synthesis and 14 case series (n = 186) in the quantitative meta-analysis. Omalizumab treatment significantly reduced the annualized exacerbation rate compared with pretreatment (mean difference, -2.09 [95% CI, -3.07 to -1.11]; P < .01). There was a reduction in OCS use (risk difference, 0.65 [95% CI, 0.46-0.84]; P < .01), an increase in termination of OCS use (risk difference, 0.53 [95% CI, 0.24-0.82]; P < .01), and a reduction in OCS dose (milligrams per day) (mean difference, -14.62 [95% CI, -19.86 to -9.39]; P < .01) in ABPA patients receiving omalizumab. Omalizumab improved FEV Conclusions: Omalizumab treatment reduced exacerbations and OCS use, improved lung function and asthma control in patients with ABPA, and was well-tolerated. The results highlight the potential role of omalizumab in the treatment of ABPA.
MeSH term(s)	Humans ; Omalizumab/therapeutic use ; Aspergillosis, Allergic Bronchopulmonary/drug therapy ; Cystic Fibrosis/drug therapy ; Asthma/drug therapy ; Adrenal Cortex Hormones/therapeutic use
Chemical Substances	Omalizumab (2P471X1Z11) ; Adrenal Cortex Hormones
Language	English
Publishing date	2022-12-26
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2022.12.012
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Article: Biologically Relevant Murine Models of Chronic

Rodgers, Aoife M / Lindsay, Jaime / Monahan, Avril / Dubois, Alice V / Faniyi, Aduragbemi A / Plant, Barry J / Mall, Marcus A / Ekkelenkamp, Miquel B / Elborn, Stuart / Ingram, Rebecca J

Pathogens (Basel, Switzerland)

2023 Volume 12, Issue 8

Abstract: Pseudomonas aeruginosa (P. aeruginosa) ...

Abstract	Pseudomonas aeruginosa (P. aeruginosa)
Language	English
Publishing date	2023-08-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens12081053
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Article ; Online: Bridging the "Know-Do" Gaps in Five Non-Communicable Diseases Using a Common Framework Driven by Implementation Science.

Donohue, James F / Elborn, J Stuart / Lansberg, Peter / Javed, Afzal / Tesfaye, Solomon / Rugo, Hope / Duddi, Sita Ratna Devi / Jithoo, Niraksha / Huang, Pai-Hui / Subramaniam, Kannan / Ramanjinappa, Nagendra / Koltun, Arkady / Melamed, Shari / Chan, Juliana C N

Journal of healthcare leadership

2023 Volume 15, Page(s) 103–119

Abstract: According to the United Nations High-Level Meeting 2018, five non-communicable diseases (NCDs) including cardiovascular diseases, chronic respiratory diseases, diabetes mellitus, cancer, and mental health conditions accounted for two-thirds of global ... ...

Abstract	According to the United Nations High-Level Meeting 2018, five non-communicable diseases (NCDs) including cardiovascular diseases, chronic respiratory diseases, diabetes mellitus, cancer, and mental health conditions accounted for two-thirds of global deaths. These five NCDs share five common risk factors including tobacco use, unhealthy diets, physical inactivity, alcohol use, and air pollution. Low- and middle-income countries (LMICs) face larger burden of NCDs than high-income countries (HICs), due to differences in ecological, technological, socioeconomic and health system development. Based on high-level evidence albeit mainly from HICs, the burden caused by NCDs can be reduced by affordable medicines and best practices. However, "know-do" gaps, ie, gaps between what we know in science and what we do in practice, has limited the impact of these strategies, especially in LMICs. Implementation science advocates the use of robust methodologies to evaluate sustainable solutions in health, education and social care aimed at informing practice and policies. In this article, physician researchers with expertise in NCDs reviewed the common challenges shared by these five NCDs with different clinical courses. They explained the principles of implementation science and advocated the use of an evidence-based framework to implement solutions focusing on early detection, prevention and empowerment, supplemented by best practices in HICs and LMICs. These successful stories can be used to motivate policymakers, payors, providers, patients and public to co-design frameworks and implement context-relevant, multi-component, evidence-based practices. In pursuit of this goal, we propose partnership, leadership, and access to continuing care as the three pillars in developing roadmaps for addressing the multiple needs during the journey of a person with or at risk of these five NCDs. By transforming the ecosystem, raising awareness and aligning context-relevant practices and policies with ongoing evaluation, it is possible to make healthcare accessible, affordable and sustainable to reduce the burden of these five NCDs.
Language	English
Publishing date	2023-07-03
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2587466-4
ISSN	1179-3201 ; 1179-3201
ISSN (online)	1179-3201
ISSN	1179-3201
DOI	10.2147/JHL.S394088
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Article: Practical management of cystic fibrosis.

Elborn, J S

Chronic respiratory disease

2006 Volume 3, Issue 3, Page(s) 161–165

MeSH term(s)	Burkholderia Infections/mortality ; Burkholderia Infections/prevention & control ; Burkholderia cepacia ; Cross Infection ; Cystic Fibrosis/microbiology ; Cystic Fibrosis/mortality ; Cystic Fibrosis/therapy ; Humans ; Lung Transplantation ; Prognosis ; Pseudomonas Infections/mortality
Language	English
Publishing date	2006
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2211488-9
ISSN	1479-9731 ; 1479-9723
ISSN (online)	1479-9731
ISSN	1479-9723
DOI	10.1191/1479972306cd111rs
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