Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study. Issue 5 (24th May 2019)

• Record Type: Journal Article
• Authors: Albasanz-Puig, Adaia; Gudiol, Carlota; Parody, Rocío; Tebe, Cristian; Akova, Murat; Araos, Rafael; Bote, Anna; Brunel, Anne-Sophie; Calik, Sebnem; Drgona, Lubos; García, Estefanía; Hemmati, Philipp; Herrera, Fabián; Ibrahim, Karim Yaqub; Isler, Burcu; Kanj, Souha; Kern, Winfried; Maestro de la Calle, Guillermo; Manzur, Adriana; Marin, Jorge Iván; Márquez-Gómez, Ignacio; Martín-Dávila, Pilar; Mikulska, Malgorzata; Montejo, José Miguel; Montero, Milagros; Morales, Hugo Manuel Paz; Morales, Isabel; Novo, Andrés; Oltolini, Chiara; Peghin, Maddalena; del Pozo, Jose Luis; Puerta-Alcalde, Pedro; Ruiz-Camps, Isabel; Sipahi, Oguz Resat; Tilley, Robert; Yáñez, Lucrecia; Gomes, Marisa Zenaide Ribeiro; Carratalà, Jordi;
• Other Names: author non-byline.; Cuervo Guillermo author non-byline.; Escrihuela-Vidal Francesc author non-byline.; Arias Marisol Rodríguez author non-byline.; Ayaz Caglayan Merve author non-byline.; Munita Jose author non-byline.; Gasch Oriol author non-byline.; Bochud Pierre-Yves author non-byline.; Manuel Oriol author non-byline.; Torres Diego author non-byline.; Zein Saeed El author non-byline.; Jabbour Jean-Francois author non-byline.; Bertz Hartmut author non-byline.; Peyerl-Hoffmann Gabriele author non-byline.; Lizasoain Manuel author non-byline.; Aguado José María author non-byline.; Palop Begoña author non-byline.; Fortún Jesús author non-byline.; Maschmeyer Georg author non-byline.; Magnasco Laura author non-byline.; Céspedes Roberto author non-byline.; López-Soria Leire author non-byline.; Horcajada Juan Pablo author non-byline.; Montaguti Mia Hold author non-byline.; Cueto Marina de author non-byline.; Rodríguez-Baño Jesús author non-byline.; Greco Raffaella author non-byline.; Cichero Paola author non-byline.; Bassetti Matteo author non-byline.; Castaldo Nadia author non-byline.; del Alcázar Paloma Sangro author non-byline.; Cardozo Celia author non-byline.; Garcia-Vidal Carolina author non-byline.; Aguilar-Company Juan author non-byline.; Larrosa Nieves author non-byline.; Uyan-Onal Ayse author non-byline.; Nazli-Zeka Arzu author non-byline.; Eylul Dokuz author non-byline.; Turkey Izmir author non-byline.; Clemencia Correa Lina author non-byline.; de Freitas Wania Vasconcelos author non-byline.; da Silva Machado Amanda Aparecida author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 5(2019)
• Publication Date: 2019-05-24
• Subjects: pseudomonas aeruginosa -- onco-haematological patients -- bacteraemia -- bloodstream infection -- neutropenia -- multidrug-resistant; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-025744
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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.