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4. The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridioides difficileinfection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Author

Mullish, Benjamin H, primary, Merrick, Blair, additional, Quraishi, Mohammed Nabil, additional, Bak, Aggie, additional, Green, Christopher A, additional, Moore, David J, additional, Porter, Robert J, additional, Elumogo, Ngozi T, additional, Segal, Jonathan P, additional, Sharma, Naveen, additional, Marsh, Belinda, additional, Kontkowski, Graziella, additional, Manzoor, Susan E, additional, Hart, Ailsa L, additional, Settle, Christopher, additional, Keller, Josbert J, additional, Hawkey, Peter, additional, Iqbal, Tariq H, additional, Goldenberg, Simon D, additional, and Williams, Horace R T, additional

Published
2024
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7. The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey

Author

Baunwall, Simon Mark Dahl, Terveer, Elisabeth M, Dahlerup, Jens Frederik, Erikstrup, Christian, Arkkila, Perttu, Vehreschild, Maria JGT, Ianiro, Gianluca, Gasbarrini, Antonio, Sokol, Harry, Kump, Patrizia K, Satokari, Reetta, De Looze, Danny, Vermeire, Séverine, Nakov, Radislav, Brezina, Jan, Helms, Morten, Kjeldsen, Jens, Rode, Anne A, Kousgaard, Sabrina Just, Alric, Laurent, Trang-Poisson, Caroline, Scanzi, Julien, Link, Alexander, Stallmach, Andreas, Kupcinskas, Juozas, Johnsen, Peter Holger, Garborg, Kjetil, Rodríguez, Eugenia Sánchez, Serrander, Lena, Brummer, Robert J, Galpérine, Katerina Tatiana, Goldenberg, Simon D, Mullish, Benjamin H, Williams, Horace RT, Iqbal, Tariq H, Ponsioen, Cyriel, Kuijper, Ed J, Cammarota, Giovanni, Keller, Josbert J, and Hvas, Christian Lodberg

Published
2021
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9. 341. Attitudes and Experiences of Individuals Approached to Participate in a Randomised, Placebo-Controlled, Feasibility Study of Encapsulated Faecal Microbiota Transplantation (FMT) for the Eradication of Gastrointestinal (GI) Carriage of Antibiotic Resistant Organisms (ARO): a Nested Qualitative Study

Author

Merrick, Blair, primary, Prossomariti, Désirée, additional, Kertanegara, Michael, additional, Wyatt, David, additional, and Goldenberg, Simon D, additional

Published
2023
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10. 293. Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organism: a prospective, randomised placebo-controlled feasibility trial - The FERARO study (IRCTN reg. no. 34467677)

Author

Merrick, Blair, primary, Prossomariti, Désirée, additional, Kertanegara, Michael, additional, Allen, Elizabeth, additional, Sergaki, Chrysi, additional, Le Guennec, Adrien D, additional, Delord, Marc, additional, Conte, Maria R, additional, Moyes, David, additional, Shankar-Hari, Manu, additional, Douiri, Abdel, additional, Goodman, Anna L, additional, Shawcross, Debbie L, additional, and Goldenberg, Simon D, additional

Published
2023
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12. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial

Author

Guery, Benoit, Menichetti, Francesco, Anttila, Veli-Jukka, Adomakoh, Nicholas, Aguado, Jose Maria, Bisnauthsing, Karen, Georgopali, Areti, Goldenberg, Simon D, Karas, Andreas, Kazeem, Gbenga, Longshaw, Chris, Palacios-Fabrega, Jose Alejandro, Cornely, Oliver A, and Vehreschild, Maria J G T

Published
2018
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20. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides difficileinfection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Author

Mullish, Benjamin H, Merrick, Blair, Quraishi, Mohammed Nabil, Bak, Aggie, Green, Christopher A, Moore, David J, Porter, Robert J, Elumogo, Ngozi T, Segal, Jonathan P, Sharma, Naveen, Marsh, Belinda, Kontkowski, Graziella, Manzoor, Susan E, Hart, Ailsa L, Settle, Christopher, Keller, Josbert J, Hawkey, Peter, Iqbal, Tariq H, Goldenberg, Simon D, and Williams, Horace R T

Abstract

The first British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS)-endorsed faecal microbiota transplant (FMT) guidelines were published in 2018. Over the past 5 years, there has been considerable growth in the evidence base (including publication of outcomes from large national FMT registries), necessitating an updated critical review of the literature and a second edition of the BSG/HIS FMT guidelines. These have been produced in accordance with National Institute for Health and Care Excellence-accredited methodology, thus have particular relevance for UK-based clinicians, but are intended to be of pertinence internationally. This second edition of the guidelines have been divided into recommendations, good practice points and recommendations against certain practices. With respect to FMT for Clostridioides difficileinfection (CDI), key focus areas centred around timing of administration, increasing clinical experience of encapsulated FMT preparations and optimising donor screening. The latter topic is of particular relevance given the COVID-19 pandemic, and cases of patient morbidity and mortality resulting from FMT-related pathogen transmission. The guidelines also considered emergent literature on the use of FMT in non-CDI settings (including both gastrointestinal and non-gastrointestinal indications), reviewing relevant randomised controlled trials. Recommendations are provided regarding special areas (including compassionate FMT use), and considerations regarding the evolving landscape of FMT and microbiome therapeutics.

Published
2024
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30. sj-pdf-1-tai-10.1177_2049936120981526 – Supplemental material for The role of faecal microbiota transplantation: looking beyond Clostridioides difficile infection

Author

Goldenberg, Simon D. and Merrick, Blair

Subjects
110203 Respiratory Diseases, 111099 Nursing not elsewhere classified, fluids and secretions, FOS: Clinical medicine, 111799 Public Health and Health Services not elsewhere classified, FOS: Health sciences, 111403 Paediatrics, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental material, sj-pdf-1-tai-10.1177_2049936120981526 for The role of faecal microbiota transplantation: looking beyond Clostridioides difficile infection by Simon D. Goldenberg and Blair Merrick in Therapeutic Advances in Infectious Disease

Published
2021
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31. A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group

Author

Keller, Josbert J., Ooijevaar, Rogier E., Hvas, Christian L., Terveer, Elisabeth M., Lieberknecht, Simone C., Hogenauer, Christoph, Arkkila, Perttu, Sokol, Harry, Gridnyev, Oleksiy, Megraud, Francis, Kump, Patrizia K., Nakov, Radislav, Goldenberg, Simon D., Satokari, Reetta, Tkatch, Sergiy, Sanguinetti, Maurizio, Cammarota, Giovanni, Dorofeev, Andrey, Gubska, Olena, Laniro, Gianluca, Mattila, Eero, Arasaradnam, Ramesh P., Sarin, Shiv K., Sood, Ajit, Putignani, Lorenza, Alric, Laurent, Baunwall, Simon M. D., Kupcinskas, Juozas, Link, Alexander, Goorhuis, Abraham G., Verspaget, Hein W., Ponsioen, Cyriel, Hold, Georgina L., Tilg, Herbert, Kassam, Zain, Kuijper, Ed J., Gasbarrini, Antonio, Mulder, Chris J. J., Williams, Horace R. T., Vehreschild, Maria J. G. T., Keller, Josbert J., Ooijevaar, Rogier E., Hvas, Christian L., Terveer, Elisabeth M., Lieberknecht, Simone C., Hogenauer, Christoph, Arkkila, Perttu, Sokol, Harry, Gridnyev, Oleksiy, Megraud, Francis, Kump, Patrizia K., Nakov, Radislav, Goldenberg, Simon D., Satokari, Reetta, Tkatch, Sergiy, Sanguinetti, Maurizio, Cammarota, Giovanni, Dorofeev, Andrey, Gubska, Olena, Laniro, Gianluca, Mattila, Eero, Arasaradnam, Ramesh P., Sarin, Shiv K., Sood, Ajit, Putignani, Lorenza, Alric, Laurent, Baunwall, Simon M. D., Kupcinskas, Juozas, Link, Alexander, Goorhuis, Abraham G., Verspaget, Hein W., Ponsioen, Cyriel, Hold, Georgina L., Tilg, Herbert, Kassam, Zain, Kuijper, Ed J., Gasbarrini, Antonio, Mulder, Chris J. J., Williams, Horace R. T., and Vehreschild, Maria J. G. T.

Abstract

Background Faecal microbiota transplantation is an emerging therapeutic option, particularly for the treatment of recurrent Clostridioides difficile infection. Stool banks that organise recruitment and screening of faeces donors are being embedded within the regulatory frameworks described in the European Union Tissue and Cells Directive and the technical guide to the quality and safety of tissue and cells for human application, published by the European Council. Objective Several European and international consensus statements concerning faecal microbiota transplantation have been issued. While these documents provide overall guidance, we aim to provide a detailed description of all processes that relate to the collection, handling and clinical application of human donor stool in this document. Methods Collaborative subgroups of experts on stool banking drafted concepts for all domains pertaining to stool banking. During a working group meeting in the United European Gastroenterology Week 2019 in Barcelona, these concepts were discussed and finalised to be included in our overall guidance document about faecal microbiota transplantation. Results A guidance document for all domains pertaining to stool banking was created. This document includes standard operating manuals for several processes involved with stool banking, such as handling of donor material, storage and donor screening. Conclusion The implementation of faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.

Published
2021

32. The use of Faecal Microbiota Transplantation (FMT) in Europe:A Europe-wide survey

Author

Baunwall, Simon Mark Dahl, Terveer, Elisabeth M., Dahlerup, Jens Frederik, Erikstrup, Christian, Arkkila, Perttu, Vehreschild, Maria JGT, Ianiro, Gianluca, Gasbarrini, Antonio, Sokol, Harry, Kump, Patrizia K., Satokari, Reetta, De Looze, Danny, Vermeire, Séverine, Nakov, Radislav, Brezina, Jan, Helms, Morten, Kjeldsen, Jens, Rode, Anne A., Kousgaard, Sabrina Just, Alric, Laurent, Trang-Poisson, Caroline, Scanzi, Julien, Link, Alexander, Stallmach, Andreas, Kupcinskas, Juozas, Johnsen, Peter Holger, Garborg, Kjetil, Rodríguez, Eugenia Sánchez, Serrander, Lena, Brummer, Robert J., Galpérine, Katerina Tatiana, Goldenberg, Simon D., Mullish, Benjamin H., Williams, Horace RT, Iqbal, Tariq H., Ponsioen, Cyriel, Kuijper, Ed J., Cammarota, Giovanni, Keller, Josbert J., Hvas, Christian Lodberg, Baunwall, Simon Mark Dahl, Terveer, Elisabeth M., Dahlerup, Jens Frederik, Erikstrup, Christian, Arkkila, Perttu, Vehreschild, Maria JGT, Ianiro, Gianluca, Gasbarrini, Antonio, Sokol, Harry, Kump, Patrizia K., Satokari, Reetta, De Looze, Danny, Vermeire, Séverine, Nakov, Radislav, Brezina, Jan, Helms, Morten, Kjeldsen, Jens, Rode, Anne A., Kousgaard, Sabrina Just, Alric, Laurent, Trang-Poisson, Caroline, Scanzi, Julien, Link, Alexander, Stallmach, Andreas, Kupcinskas, Juozas, Johnsen, Peter Holger, Garborg, Kjetil, Rodríguez, Eugenia Sánchez, Serrander, Lena, Brummer, Robert J., Galpérine, Katerina Tatiana, Goldenberg, Simon D., Mullish, Benjamin H., Williams, Horace RT, Iqbal, Tariq H., Ponsioen, Cyriel, Kuijper, Ed J., Cammarota, Giovanni, Keller, Josbert J., and Hvas, Christian Lodberg

Abstract

Background: Faecal microbiota transplantation (FMT) is an emerging treatment modality, but its current clinical use and organisation are unknown. We aimed to describe the clinical use, conduct, and potential for FMT in Europe. Methods: We invited all hospital-based FMT centres within the European Council member states to answer a web-based questionnaire covering their clinical activities, organisation, and regulation of FMT in 2019. Responders were identified from trials registered at clinicaltrials.gov and from the United European Gastroenterology (UEG) working group for stool banking and FMT. Findings: In 2019, 31 FMT centres from 17 countries reported a total of 1,874 (median 25, quartile 10–64) FMT procedures; 1,077 (57%) with Clostridioides difficile infection (CDI) as indication, 791 (42%) with experimental indications, and 6 (0•3%) unaccounted for. Adjusted to population size, 0•257 per 100,000 population received FMT for CDI and 0•189 per 100,000 population for experimental indications. With estimated 12,400 (6,100–28,500) annual cases of multiple, recurrent CDI and indication for FMT in Europe, the current European FMT activity covers approximately 10% of the patients with indication. The participating centres demonstrated high safety standards and adherence to international consensus guidelines. Formal or informal regulation from health authorities was present at 21 (68%) centres. Interpretation: FMT is a widespread routine treatment for multiple, recurrent CDI and an experimental treatment. Embedded within hospital settings, FMT centres operate with high standards across Europe to provide safe FMT. A significant gap in FMT coverage suggests the need to raise clinical awareness and increase the FMT activity in Europe by at least 10-fold to meet the true, indicated need. Funding: NordForsk under the Nordic Council and Innovation Fund Denmark (j.no. 8056–00006B).

Published
2021

34. A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group

Author

Keller, Josbert J., primary, Ooijevaar, Rogier E., additional, Hvas, Christian L., additional, Terveer, Elisabeth M., additional, Lieberknecht, Simone C., additional, Högenauer, Christoph, additional, Arkkila, Perttu, additional, Sokol, Harry, additional, Gridnyev, Oleksiy, additional, Mégraud, Francis, additional, Kump, Patrizia K., additional, Nakov, Radislav, additional, Goldenberg, Simon D., additional, Satokari, Reetta, additional, Tkatch, Sergiy, additional, Sanguinetti, Maurizio, additional, Cammarota, Giovanni, additional, Dorofeev, Andrey, additional, Gubska, Olena, additional, Ianiro, Gianluca, additional, Mattila, Eero, additional, Arasaradnam, Ramesh P., additional, Sarin, Shiv K., additional, Sood, Ajit, additional, Putignani, Lorenza, additional, Alric, Laurent, additional, Baunwall, Simon M. D., additional, Kupcinskas, Juozas, additional, Link, Alexander, additional, Goorhuis, Abraham G., additional, Verspaget, Hein W., additional, Ponsioen, Cyriel, additional, Hold, Georgina L., additional, Tilg, Herbert, additional, Kassam, Zain, additional, Kuijper, Ed J., additional, Gasbarrini, Antonio, additional, Mulder, Chris J. J., additional, Williams, Horace R. T., additional, and Vehreschild, Maria J. G. T., additional

Published
2021
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35. sj-pdf-1-ueg-10.1177_2050640620967898 - Supplemental material for A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group

Author

Josbert J Keller, Ooijevaar, Rogier E, Hvas, Christian L, Terveer, Elisabeth M, Lieberknecht, Simone C, Högenauer, Christoph, Arkkila, Perttu, Sokol, Harry, Gridnyev, Oleksiy, Mégraud, Francis, Kump, Patrizia K, Nakov, Radislav, Goldenberg, Simon D, Satokari, Reetta, Tkatch, Sergiy, Sanguinetti, Maurizio, Cammarota, Giovanni, Dorofeev, Andrey, Gubska, Olena, Ianiro, Gianluca, Mattila, Eero, Arasaradnam, Ramesh P, Sarin, Shiv K, Sood, Ajit, Putignani, Lorenza, Alric, Laurent, Simon MD Baunwall, Kupcinskas, Juozas, Link, Alexander, Goorhuis, Abraham G, Verspaget, Hein W, Cyriel Ponsioen, Hold, Georgina L, Tilg, Herbert, Zain Kassam, Kuijper, Ed J, Gasbarrini, Antonio, Mulder, Chris JJ, Williams, Horace RT, and Vehreschild, Maria JGT

Subjects
FOS: Clinical medicine, FOS: Biological sciences, 111199 Nutrition and Dietetics not elsewhere classified, FOS: Health sciences, 110308 Geriatrics and Gerontology, 69999 Biological Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-pdf-1-ueg-10.1177_2050640620967898 for A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group by Josbert J Keller, Rogier E Ooijevaar, Christian L Hvas, Elisabeth M Terveer, Simone C Lieberknecht, Christoph Högenauer, Perttu Arkkila, Harry Sokol, Oleksiy Gridnyev, Francis Mégraud, Patrizia K Kump, Radislav Nakov, Simon D Goldenberg, Reetta Satokari, Sergiy Tkatch, Maurizio Sanguinetti, Giovanni Cammarota, Andrey Dorofeev, Olena Gubska, Gianluca Ianiro, Eero Mattila, Ramesh P Arasaradnam, Shiv K Sarin, Ajit Sood, Lorenza Putignani, Laurent Alric, Simon MD Baunwall, Juozas Kupcinskas, Alexander Link, Abraham G Goorhuis, Hein W Verspaget, Cyriel Ponsioen, Georgina L Hold, Herbert Tilg, Zain Kassam, Ed J Kuijper, Antonio Gasbarrini, Chris JJ Mulder, Horace RT Williams and Maria JGT Vehreschild in United European Gastroenterology Journal

Published
2020
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36. Donated stool for faecal microbiota transplantation is not a drug, but guidance and regulation are needed

Author

Keller, Josbert J., Vehreschild, Maria J. G. T., Hvas, Christian L., Jorgensen, Simon M. D., Kupcinskas, Juozas, Link, Alexander, Mulder, Chris J. J., Goldenberg, Simon D., Arasaradnam, Ramesh, Sokol, Harry, Gasbarrini, Antonio, Hoegenauer, Christoph, Terveer, Elizabeth M., Kuijper, Ed J., Arkkila, Perttu, Keller, Josbert J., Vehreschild, Maria J. G. T., Hvas, Christian L., Jorgensen, Simon M. D., Kupcinskas, Juozas, Link, Alexander, Mulder, Chris J. J., Goldenberg, Simon D., Arasaradnam, Ramesh, Sokol, Harry, Gasbarrini, Antonio, Hoegenauer, Christoph, Terveer, Elizabeth M., Kuijper, Ed J., and Arkkila, Perttu

Published
2020

37. Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO): a prospective, randomised placebo-controlled feasibility trial

Author

Merrick, Blair, primary, Robinson, Emily, additional, Bunce, Catey, additional, Allen, Liz, additional, Bisnauthsing, Karen, additional, Izundu, Chi Chi, additional, Bell, Jordana, additional, Amos, Gregory, additional, Shankar-Hari, Manu, additional, Goodman, Anna, additional, Shawcross, Debbie L, additional, and Goldenberg, Simon D, additional

Published
2020
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38. Detecting SARS-CoV-2 at point of care: Preliminary data comparing Loop-mediated isothermal amplification (LAMP) to PCR

Author

Österdahl, Marc F, primary, Lee, Karla A, additional, Lochlainn, Mary Ni, additional, Wilson, Stuart, additional, Douthwaite, Sam, additional, Horsfall, Rachel, additional, Sheedy, Alyce, additional, Goldenberg, Simon D, additional, Stanley, Christopher J, additional, Spector, Tim D, additional, and Steves, Claire J, additional

Published
2020
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39. Donated stool for faecal microbiota transplantation is not a drug, but guidance and regulation are needed

Author

Keller, Josbert J, primary, Vehreschild, Maria JGT, additional, Hvas, Christian L, additional, Jørgensen, Simon MD, additional, Kupcinskas, Juozas, additional, Link, Alexander, additional, Mulder, Chris JJ, additional, Goldenberg, Simon D, additional, Arasaradnam, Ramesh, additional, Sokol, Harry, additional, Gasbarrini, Antonio, additional, Hoegenauer, Christoph, additional, Terveer, Elizabeth M, additional, Kuijper, Ed J, additional, and Arkkila, Perttu, additional

Published
2020
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40. Evidence for community transmission of community-associated but not health-care-associated methicillin-resistant Staphylococcus aureus strains linked to social and material deprivation: spatial analysis of cross-sectional data

Author

Auguet, Olga Tosas, Betley, Jason R., Stabler, Richard A., Patel, Amita, Ioannou, Avgousta, Marbach, Helene, Hearn, Pasco, Aryee, Anna, Goldenberg, Simon D., Otter, Jonathan A., Desai, Nergish, Karadag, Tacim, Grundy, Chris, Gaunt, Michael W., Cooper, Ben S., Edgeworth, Jonathan D., and Kypraios, Theodore

Subjects
Staphylococcus aureus -- Health aspects -- Social aspects, Disease transmission -- Control -- Social aspects, Public health -- Management, Company business management, Biological sciences
Abstract

Background Identifying and tackling the social determinants of infectious diseases has become a public health priority following the recognition that individuals with lower socioeconomic status are disproportionately affected by infectious diseases. In many parts of the world, epidemiologically and genotypically defined community-associated (CA) methicillin-resistant Staphylococcus aureus (MRSA) strains have emerged to become frequent causes of hospital infection. The aim of this study was to use spatial models with adjustment for area-level hospital attendance to determine the transmission niche of genotypically defined CA- and health-care-associated (HA)-MRSA strains across a diverse region of South East London and to explore a potential link between MRSA carriage and markers of social and material deprivation. Methods and Findings This study involved spatial analysis of cross-sectional data linked with all MRSA isolates identified by three National Health Service (NHS) microbiology laboratories between 1 November 2011 and 29 February 2012. The cohort of hospital-based NHS microbiology diagnostic services serves 867,254 usual residents in the Lambeth, Southwark, and Lewisham boroughs in South East London, United Kingdom (UK). Isolates were classified as HA- or CA-MRSA based on whole genome sequencing. All MRSA cases identified over 4 mo within the three-borough catchment area (n = 471) were mapped to small geographies and linked to area-level aggregated socioeconomic and demographic data. Disease mapping and ecological regression models were used to infer the most likely transmission niches for each MRSA genetic classification and to describe the spatial epidemiology of MRSA in relation to social determinants. Specifically, we aimed to identify demographic and socioeconomic population traits that explain cross-area extra variation in HA- and CA-MRSA relative risks following adjustment for hospital attendance data. We explored the potential for associations with the English Indices of Deprivation 2010 (including the Index of Multiple Deprivation and several deprivation domains and subdomains) and the 2011 England and Wales census demographic and socioeconomic indicators (including numbers of households by deprivation dimension) and indicators of population health. Both CA-and HA-MRSA were associated with household deprivation (CA-MRSA relative risk [RR]: 1.72 [1.03-2.94]; HA-MRSA RR: 1.57 [1.06-2.33]), which was correlated with hospital attendance (Pearson correlation coefficient [PCC] = 0.76). HA-MRSA was also associated with poor health (RR: 1.10 [1.01-1.19]) and residence in communal care homes (RR: 1.24 [1.12-1.37]), whereas CA-MRSA was linked with household overcrowding (RR: 1.58 [1.04-2.41]) and wider barriers, which represent a combined score for household overcrowding, low income, and homelessness (RR: 1.76 [1.16-2.70]). CA-MRSA was also associated with recent immigration to the UK (RR: 1.77 [1.19-2.66]). For the area-level variation in RR for CA-MRSA, 28.67% was attributable to the spatial arrangement of target geographies, compared with only 0.09% for HA-MRSA. An advantage to our study is that it provided a representative sample of usual residents receiving care in the catchment areas. A limitation is that relationships apparent in aggregated data analyses cannot be assumed to operate at the individual level. Conclusions There was no evidence of community transmission of HA-MRSA strains, implying that HA-MRSA cases identified in the community originate from the hospital reservoir and are maintained by frequent attendance at health care facilities. In contrast, there was a high risk of CA-MRSA in deprived areas linked with overcrowding, homelessness, low income, and recent immigration to the UK, which was not explainable by health care exposure. Furthermore, areas adjacent to these deprived areas were themselves at greater risk of CA-MRSA, indicating community transmission of CA-MRSA. This ongoing community transmission could lead to CA-MRSA becoming the dominant strain types carried by patients admitted to hospital, particularly if successful hospital-based MRSA infection control programmes are maintained. These results suggest that community infection control programmes targeting transmission of CA-MRSA will be required to control MRSA in both the community and hospital. These epidemiological changes will also have implications for effectiveness of risk-factor-based hospital admission MRSA screening programmes., Introduction In recent years, systematic health inequalities and the uneven distribution of adverse health outcomes have been found to affect a wide array of infectious diseases, not just chronic diseases [...]

Published
2016
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41. Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CDI, renal impairment or hepatic impairment: a retrospective study of routine clinical use (ANEMONE)

Author

Vehreschild, Maria J G T, Taori, Surabhi, Goldenberg, Simon D, Thalhammer, Florian, Bouza, Emilio, van Oene, Joop, Wetherill, Graham, and Georgopali, Areti

Subjects
Adult, Adolescent, Liver Diseases, Clostridium difficile, Kaplan-Meier Estimate, Fulminant CDI, Middle Aged, Inflammatory Bowel Diseases, Inflammatory bowel disease, Hepatic impairment, Anti-Bacterial Agents, Electrocardiography, Young Adult, Clostridium Infections, Humans, Renal Insufficiency, Renal impairment, Child, Fidaxomicin, Follow-Up Studies, Retrospective Studies
Abstract

Information is limited or lacking on fidaxomicin treatment of Clostridium difficile infection (CDI) in patients with inflammatory bowel disease, fulminant or life-threatening CDI, severe renal impairment, moderate-to-severe hepatic impairment and pregnancy. The ANEMONE study investigated fidaxomicin use in a routine clinical setting, focusing on these medical conditions of specific interest (MCSIs). This retrospective, post-authorisation study reviewed hospital records from Austria, Germany, Spain and the UK (June 2012-June 2015), collecting data from hospital admission to 30 days after last fidaxomicin dose. The primary objective was to identify the proportion of fidaxomicin-treated patients with MCSIs. Secondary objectives were to describe 30-day mortality, changes in ECG and laboratory parameters, fidaxomicin exposure and CDI response (resolution of diarrhoea; 30-day recurrence). 45.3% (261/576) of patients had ≥ 1 MCSI. Thirty-day mortality (post-first dose) was 17.0% (98/576) in the total population and slightly higher (24.6-27.6%) in patients with fulminant CDI or severe renal impairment. 29.6% (24/81) deaths of known cause were attributable to CDI. Of changes in laboratory parameters or ECG findings, only a decrease in leucocyte counts appeared associated with fidaxomicin, consistent with a positive treatment response. Diarrhoea resolved in 78.0% (404/518) of treatment episodes; diarrhoea resolution was lowest in patients with fulminant CDI (investigator-defined, 67.5%, 56/88) and severe renal impairment (68.0%, 68/100). Thirty-day recurrence (18.8%, 79/420) was similar across MCSI subgroups. Although almost half of fidaxomicin-treated patients had ≥ 1 MCSI, the majority of patients in all subgroups had positive responses to treatment, and no particular safety concerns were identified.

Published
2018

44. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients aged >= 60 years (EXTEND): analysis of cost-effectiveness

Author

Cornely, Oliver A., Watt, Maureen, McCrea, Charles, Goldenberg, Simon D., De Nigris, Enrico, Cornely, Oliver A., Watt, Maureen, McCrea, Charles, Goldenberg, Simon D., and De Nigris, Enrico

Abstract

Objectives: The randomized Phase IIIb/IV EXTEND trial showed that extended-pulsed fidaxomicin significantly improved sustained clinical cure and reduced recurrence versus vancomycin in patients >= 60 years old with Clostridium difficile infection (CDI). Cost-effectiveness of extended-pulsed fidaxomicin versus vancomycin as first-line therapy for CDI was evaluated in this patient population. Methods: Clinical results from EXTEND and inputs from published sources were used in a semi-Markov treatment-sequence model with nine health states and a 1 year time horizon to assess costs and QALYs. The model was based on a healthcare system perspective (NHS and Personal Social Services) in England. Sensitivity analyses were performed. Results: Patients receiving first-line extended-pulsed fidaxomicin treatment had a 0.02 QALY gain compared with first-line vancomycin (0.6267 versus 0.6038 QALYs/patient). While total drug acquisition costs were higher for extended-pulsed fidaxomicin than for vancomycin when used first-line (1356 pound versus 260 pound/patient), these were offset by lower total hospitalization costs (which also included treatment monitoring and community care costs; 10 pound 815 versus 11459 pound/patient) and lower costs of managing adverse events (694 pound versus 1199 pound/patient), reflecting the lower incidence of CDI recurrence and adverse events with extended-pulsed fidaxomicin. Extended-pulsed fidaxomicin cost 53 pound less per patient than vancomycin over 1 year. The probability that first-line extended-pulsed fidaxomicin was cost-effective at a willingness-to-pay threshold of 30 pound 000/QALY was 76% in these patients. Conclusions: While fidaxomicin acquisition costs are higher than those of vancomycin, the observed reduced recurrence rate with extended-pulsed fidaxomicin makes it a more effective and less costly treatment strategy than vancomycin for first-line treatment of CDI in older patients.

Published
2018

46. Correction to: Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CDI, renal impairment or hepatic impairment: a retrospective study of routine clinical use (ANEMONE)

Author

Vehreschild, Maria J. G. T., primary, Taori, Surabhi, additional, Goldenberg, Simon D., additional, Thalhammer, Florian, additional, Bouza, Emilio, additional, van Oene, Joop, additional, Wetherill, Graham, additional, and Georgopali, Areti, additional

Published
2018
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47. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Author

Mullish, Benjamin H., primary, Quraishi, Mohammed Nabil, additional, Segal, Jonathan P., additional, McCune, Victoria L., additional, Baxter, Melissa, additional, Marsden, Gemma L., additional, Moore, David, additional, Colville, Alaric, additional, Bhala, Neeraj, additional, Iqbal, Tariq H., additional, Settle, Christopher, additional, Kontkowski, Graziella, additional, Hart, Ailsa L., additional, Hawkey, Peter M., additional, Williams, Horace RT, additional, and Goldenberg, Simon D., additional

Published
2018
Full Text
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48. The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Author

Mullish, Benjamin H, primary, Quraishi, Mohammed Nabil, additional, Segal, Jonathan P, additional, McCune, Victoria L, additional, Baxter, Melissa, additional, Marsden, Gemma L, additional, Moore, David J, additional, Colville, Alaric, additional, Bhala, Neeraj, additional, Iqbal, Tariq H, additional, Settle, Christopher, additional, Kontkowski, Graziella, additional, Hart, Ailsa L, additional, Hawkey, Peter M, additional, Goldenberg, Simon D, additional, and Williams, Horace R T, additional

Published
2018
Full Text
View/download PDF

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