dc.creator | Molina, José | es |
dc.creator | Rosso-Fernández, Clara María | es |
dc.creator | Montero-Mateos, Enrique | es |
dc.creator | Paño-Pardo, José Ramón | es |
dc.creator | Solla, María | es |
dc.creator | Guisado Gil, Ana Belén | es |
dc.creator | Lepe Jiménez, José Antonio | es |
dc.creator | Cisneros, José Miguel | es |
dc.date.accessioned | 2024-01-30T14:07:21Z | |
dc.date.available | 2024-01-30T14:07:21Z | |
dc.date.issued | 2022-12-22 | |
dc.identifier.citation | Molina, J., Rosso-Fernández, C.M., Montero-Mateos, E., Paño-Pardo, J.R., Solla, M., Guisado-Gil, A.B.,...,Cisneros, J.M. (2022). Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial). Plos One, 17 (12), e0277333. https://doi.org/10.1371/journal.pone.0277333. | |
dc.identifier.issn | 1932-6203 | es |
dc.identifier.uri | https://hdl.handle.net/11441/154258 | |
dc.description.abstract | Background
Research priorities in Antimicrobial Stewardship (AMS) have rapidly evolved in the last
decade. The need for a more efficient use of antimicrobials have fueled plenty of studies to
define the optimal duration for antibiotic treatments, and yet, there still are large areas of
uncertainty in common clinical scenarios. Pseudomonas aeruginosa has been pointed as a
priority for clinical research, but it has been unattended by most randomized trials tackling
the effectiveness of short treatments. The study protocol of the SHORTEN-2 trial is presented as a practical example of new ways to approach common obstacles for clinical
research in AMS.
Objective
To determine whether a 7-day course of antibiotics is superior to 14-day schemes for treating bloodstream infections by P. aeruginosa (BSI-PA).
Methods
A superiority, open-label, randomized controlled trial will be performed across 30 Spanish
hospitals. Adult patients with uncomplicated BSI-PA will be randomized to receive a 7 versus 14-day course of any active antibiotic. The primary endpoint will be the probability for the 7-day group of achieving better outcomes than the control group, assessing altogether
clinical effectiveness, severe adverse events, and antibiotic exposure through a DOOR/
RADAR analysis. Main secondary endpoints include treatment failure, BSI-PA relapses,
and mortality. A superiority design was set for the primary endpoint and non-inferiority for
treatment failure, resulting in a sample size of 304 patients.
Conclusions
SHORTEN-2 trial aligns with some of the priorities for clinical research in AMS. The implementation of several methodological innovations allowed overcoming common obstacles,
like feasible sample sizes or measuring the clinical impact and unintended effects. | es |
dc.format | application/pdf | es |
dc.format.extent | 14 p. | es |
dc.language.iso | eng | es |
dc.relation.ispartof | Plos One, 17 (12), e0277333. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.title | Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial) | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Microbiología | |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | |
dc.contributor.affiliation | Universidad de Sevilla. Instituto de Biomedicina de Sevilla (IBIS) | |
dc.relation.projectID | ICI21/ 00075 | es |
dc.relation.publisherversion | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0277333 | es |
dc.identifier.doi | 10.1371/journal.pone.0277333 | es |
dc.journaltitle | Plos One | es |
dc.publication.volumen | 17 | es |
dc.publication.issue | 12 | es |
dc.publication.initialPage | e0277333 | es |
dc.contributor.funder | Instituto de Salud Carlos III | es |