Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project
Introduction Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appro...
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e035460.full |
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| author | Jesús Rodríguez-Baño Zaira R Palacios-Baena Clara M Rosso-Fernández Pilar Retamar Lucia Valiente de Santis Natalia Maldonado Irene Borreguero Carmen Herrero-Rodríguez Salvador López-Cárdenas Franciso J Martínez-Marcos Andrés Martín-Aspas Patricia Jiménez-Aguilar Juan J Castón Guillermo Ojeda-Burgos M Pilar Aznarte-Padial Julia Praena-Segovia Juan E Corzo-Delgado M Ángeles Esteban-Moreno |
| author_facet | Jesús Rodríguez-Baño Zaira R Palacios-Baena Clara M Rosso-Fernández Pilar Retamar Lucia Valiente de Santis Natalia Maldonado Irene Borreguero Carmen Herrero-Rodríguez Salvador López-Cárdenas Franciso J Martínez-Marcos Andrés Martín-Aspas Patricia Jiménez-Aguilar Juan J Castón Guillermo Ojeda-Burgos M Pilar Aznarte-Padial Julia Praena-Segovia Juan E Corzo-Delgado M Ángeles Esteban-Moreno |
| author_sort | Jesús Rodríguez-Baño |
| collection | DOAJ |
| description | Introduction Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood.Methods and analysis This study will be implemented in two phases. First, a preliminary historical cohort (2017–2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020–2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence of Clostridioides difficile infection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured.Ethics and dissemination Ethical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.Trial registration number NCT03941951; Pre-results. |
| format | Article |
| id | doaj-art-ae4b720c1c1146fc8c5b50b1c0e6de45 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
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| series | BMJ Open |
| spelling | doaj-art-ae4b720c1c1146fc8c5b50b1c0e6de452024-12-04T19:00:09ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2019-035460Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE projectJesús Rodríguez-Baño0Zaira R Palacios-Baena1Clara M Rosso-Fernández2Pilar Retamar3Lucia Valiente de Santis4Natalia Maldonado5Irene Borreguero6Carmen Herrero-Rodríguez7Salvador López-Cárdenas8Franciso J Martínez-Marcos9Andrés Martín-Aspas10Patricia Jiménez-Aguilar11Juan J Castón12Guillermo Ojeda-Burgos13M Pilar Aznarte-Padial14Julia Praena-Segovia15Juan E Corzo-Delgado16M Ángeles Esteban-Moreno17Universidad de Sevilla, Instituto de Biomedicina de Sevilla (IBiS)/CSIC; CIBERINFEC, Sevilla, SpainUniversidad de Sevilla, Instituto de Biomedicina de Sevilla (IBiS)/CSIC; CIBERINFEC, Sevilla, SpainUnidad de Investigación Clínica y Ensayos Clínicos (CTU-UICEC-HUVR-HUVM), Hospital Universitario Virgen del Rocío, Sevilla, SpainDepartamentos de Medicina y Microbiología, Universidad de Sevilla, Sevilla, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Universitario Regional de Málaga, Málaga, SpainUnidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen Macarena, Sevilla, SpainUnidad de Investigación Clínica y Ensayos Clínicos (CTU), Hospital Universitario Virgen del Rocío-Macarena, Seville, SpainUnidad Clínica de Enfermedades Infecciosas, Complejo Hospitalario de Jaén, Jaén, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital de Jerez de la Frontera, Cádiz, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Juan Ramón Jiménez, Huelva, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Puerta del Mar, Cádiz, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Puerto Real, Cádiz, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, SpainUnidad Clínica de Enfermedades Infecciosas, Hospital Virgen de la Victoria, Málaga, SpainUnidad Clínica de Farmacia, Hospital Virgen de las Nieves, Granada, SpainUnidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío/ Instituto de Biomedicina de Sevilla (IBIS), Seville, SpainUnidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen de Valme, Seville, SpainInfectious Diseases Unit, Complejo Hospitalario Torrecardenas, Almeria, Andalucía, SpainIntroduction Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood.Methods and analysis This study will be implemented in two phases. First, a preliminary historical cohort (2017–2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020–2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence of Clostridioides difficile infection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured.Ethics and dissemination Ethical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.Trial registration number NCT03941951; Pre-results.https://bmjopen.bmj.com/content/10/7/e035460.full |
| spellingShingle | Jesús Rodríguez-Baño Zaira R Palacios-Baena Clara M Rosso-Fernández Pilar Retamar Lucia Valiente de Santis Natalia Maldonado Irene Borreguero Carmen Herrero-Rodríguez Salvador López-Cárdenas Franciso J Martínez-Marcos Andrés Martín-Aspas Patricia Jiménez-Aguilar Juan J Castón Guillermo Ojeda-Burgos M Pilar Aznarte-Padial Julia Praena-Segovia Juan E Corzo-Delgado M Ángeles Esteban-Moreno Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project BMJ Open |
| title | Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project |
| title_full | Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project |
| title_fullStr | Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project |
| title_full_unstemmed | Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project |
| title_short | Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project |
| title_sort | quasiexperimental intervention study protocol to optimise the use of new antibiotics in spain the new safe project |
| url | https://bmjopen.bmj.com/content/10/7/e035460.full |
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