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

Adaia Albasanz-Puig, Carlota Gudiol, Rocío Parody, Cristian Tebe, Murat Akova, Rafael Araos, Anna Bote, Anne Sophie Brunel, Sebnem Calik, Lubos Drgona, Estefanía García, Philipp Hemmati, Fabián Herrera, Karim Yaqub Ibrahim, Burcu Isler, Souha Kanj, Winfried Kern, Guillermo Maestro De La Calle, Adriana Manzur, Jorge Iván MarinIgnacio Márquez-Gómez, Pilar Martín-Dávila, Malgorzata Mikulska, José Miguel Montejo, Milagros Montero, Hugo Manuel Paz Morales, Isabel Morales, Andrés Novo, Chiara Oltolini, Maddalena Peghin, Jose Luis Del Pozo, Pedro Puerta-Alcalde, Isabel Ruiz-Camps, Oguz Resat Sipahi, Robert Tilley, Lucrecia Yáñez, Marisa Zenaide Ribeiro Gomes, Jordi Carratalà

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    © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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.
    Original languageEnglish
    Article numbere025744
    Number of pages6
    JournalBMJ Open
    Issue number5
    Publication statusPublished - 24 May 2019


    • bacteraemia
    • bloodstream infection
    • multidrug-resistant
    • neutropenia
    • onco-haematological patients
    • pseudomonas aeruginosa
    • ADULT
    • CARE


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