Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study.

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Version: Final published version
License: CC BY-NC 4.0
Serval ID
serval:BIB_047D4C880AF1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study.
Journal
BMJ open
Author(s)
Albasanz-Puig A., Gudiol C., Parody R., Tebe C., Akova M., Araos R., Bote A., Brunel A.S., Calik S., Drgona L., García E., Hemmati P., Herrera F., Ibrahim K.Y., Isler B., Kanj S., Kern W., Maestro de la Calle G., Manzur A., Marin J.I., Márquez-Gómez I., Martín-Dávila P., Mikulska M., Montejo J.M., Montero M., Morales HMP, Morales I., Novo A., Oltolini C., Peghin M., Del Pozo J.L., Puerta-Alcalde P., Ruiz-Camps I., Sipahi O.R., Tilley R., Yáñez L., Gomes MZR, Carratalà J.
Working group(s)
IRONIC study group
Contributor(s)
Cuervo G., Escrihuela-Vidal F., Arias M.R., Ayaz C.M., Munita J., Gasch O., Bochud P.Y., Manuel O., Torres D., Zein S.E., Jabbour J.F., Bertz H., Peyerl-Hoffmann G., Lizasoain M., Aguado J.M., Palop B., Fortún J., Maschmeyer G., Magnasco L., Céspedes R., López-Soria L., Horcajada J.P., Montaguti M.H., Cueto M., Rodríguez-Baño J., Greco R., Cichero P., Bassetti M., Castaldo N., Del Alcázar P.S., Cardozo C., Garcia-Vidal C., Aguilar-Company J., Larrosa N., Uyan-Onal A., Nazli-Zeka A., Eylul D., Turkey I., Clemencia Correa L., de Freitas W.V., da Silva Machado A.A.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
24/05/2019
Peer-reviewed
Oui
Volume
9
Number
5
Pages
e025744
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: epublish
Abstract
Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality.
This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic onco-haematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrug-resistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates.
The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients' personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peer-reviewed publications.
Keywords
Anti-Bacterial Agents/therapeutic use, Bacteremia/drug therapy, Bacteremia/mortality, Cephalosporins/therapeutic use, Drug Resistance, Multiple, Bacterial, Humans, International Cooperation, Logistic Models, Multicenter Studies as Topic, Neoplasms/complications, Neutropenia/complications, Observational Studies as Topic, Pseudomonas Infections/drug therapy, Pseudomonas aeruginosa/isolation & purification, Research Design, Retrospective Studies, Tazobactam/therapeutic use, Time Factors, bacteraemia, bloodstream infection, multidrug-resistant, neutropenia, onco-haematological patients, pseudomonas aeruginosa
Pubmed
Web of science
Open Access
Yes
Create date
14/06/2019 16:40
Last modification date
15/01/2021 7:08
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