Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol

Introduction Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance...

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Autores: Abelenda Alonso, Gabriela, Rombauts, Alexander, Gudiol González, Carlota, Meije, Yolanda, Clemente, Mercedes, Ortega, Lucia, Ardanuy Tisaire, María Carmen, Niubó, Jordi, Padullés Zamora, Ariadna, Videla, Sebastià, Tebé, Cristian, Carratalà, Jordi
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/173957
Acceso en línea:https://hdl.handle.net/2445/173957
Access Level:acceso abierto
Palabra clave:Pneumònia
Assaigs clínics
Antibiòtics
Pneumonia
Clinical trials
Antibiotics
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spelling Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocolAbelenda Alonso, GabrielaRombauts, AlexanderGudiol González, CarlotaMeije, YolandaClemente, MercedesOrtega, LuciaArdanuy Tisaire, María CarmenNiubó, JordiPadullés Zamora, AriadnaVidela, SebastiàTebé, CristianCarratalà, JordiPneumòniaAssaigs clínicsAntibiòticsPneumoniaClinical trialsAntibioticsIntroduction Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP. Methods and analysis We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8. Ethics and dissemination Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and fundersBMJ Publishing Group2021202120202021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion7 p.application/pdfhttps://hdl.handle.net/2445/173957Articles publicats en revistes (Ciències Clíniques)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1136/bmjopen-2020-038957BMJ Open, 2020, vol. 10, num. e038957https://doi.org/10.1136/bmjopen-2020-038957cc-by (c) Abelenda Alonso, Gabriela et al., 2020http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:recercat.cat:2445/1739572026-05-29T05:05:01Z
dc.title.none.fl_str_mv Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
title Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
spellingShingle Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
Abelenda Alonso, Gabriela
Pneumònia
Assaigs clínics
Antibiòtics
Pneumonia
Clinical trials
Antibiotics
title_short Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
title_full Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
title_fullStr Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
title_full_unstemmed Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
title_sort Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol
dc.creator.none.fl_str_mv Abelenda Alonso, Gabriela
Rombauts, Alexander
Gudiol González, Carlota
Meije, Yolanda
Clemente, Mercedes
Ortega, Lucia
Ardanuy Tisaire, María Carmen
Niubó, Jordi
Padullés Zamora, Ariadna
Videla, Sebastià
Tebé, Cristian
Carratalà, Jordi
author Abelenda Alonso, Gabriela
author_facet Abelenda Alonso, Gabriela
Rombauts, Alexander
Gudiol González, Carlota
Meije, Yolanda
Clemente, Mercedes
Ortega, Lucia
Ardanuy Tisaire, María Carmen
Niubó, Jordi
Padullés Zamora, Ariadna
Videla, Sebastià
Tebé, Cristian
Carratalà, Jordi
author_role author
author2 Rombauts, Alexander
Gudiol González, Carlota
Meije, Yolanda
Clemente, Mercedes
Ortega, Lucia
Ardanuy Tisaire, María Carmen
Niubó, Jordi
Padullés Zamora, Ariadna
Videla, Sebastià
Tebé, Cristian
Carratalà, Jordi
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Pneumònia
Assaigs clínics
Antibiòtics
Pneumonia
Clinical trials
Antibiotics
topic Pneumònia
Assaigs clínics
Antibiòtics
Pneumonia
Clinical trials
Antibiotics
description Introduction Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP. Methods and analysis We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8. Ethics and dissemination Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and funders
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/173957
url https://hdl.handle.net/2445/173957
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1136/bmjopen-2020-038957
BMJ Open, 2020, vol. 10, num. e038957
https://doi.org/10.1136/bmjopen-2020-038957
dc.rights.none.fl_str_mv cc-by (c) Abelenda Alonso, Gabriela et al., 2020
http://creativecommons.org/licenses/by/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Abelenda Alonso, Gabriela et al., 2020
http://creativecommons.org/licenses/by/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 7 p.
application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv Articles publicats en revistes (Ciències Clíniques)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.81155

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