Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study) : Study protocol of a retrospective multicentre international study
Albasanz-Puig, Adaia (Spanish Network for Research in Infectious Diseases)
Gudiol, Carlota (Spanish Network for Research in Infectious Diseases)
Parody Porras, Rocío (Institut Català d'Oncologia)
Tebe, Cristian (Institut d'Investigació Biomèdica de Bellvitge)
Akova, Murat (Infectious Diseases Department. Hacettepe University School of Medicine)
Araos, Rafael (Clínica Alemana Universidad del Desarrollo. Facultad de Medicina)
Bote, Alex (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Brunel, Anne-Sophie (Lausanne University Hospital)
Calik, Sebnem (Department of Infectious Diseases and Clinical Microbiology. University of Health Science Izmir Bozyaka Training and Research Hospital)
Drgona, Lubos (Oncohematology Department. Comenius University and National Cancer Institute)
García, Estefanía (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Hemmati, Philipp (Department of Haematology. Oncology and Palliative Care. Klinikum Ernst von Bergmann. Academic Teaching Hospital of Charite. University Medical School)
Herrera, Fabián (Infectious Diseases Section. Department of Medicine. Centro de Educación Médica e Investigaciones Clínicas)
Ibrahim, Karim Yaqub (Instituto Do Câncer Do Estado de São Paulo. Faculdade de Medicina da Universidade de São)
Isler, Burcu (Department of Infectious Diseases and Clinical Microbiology. Istanbul Education and Research Hospital)
Kanj, Souha (Infectious Diseases Division. American University of Beirut Medical Center)
Kern, Winfried (Division of Infectious Diseases. Department of Medicine II. University of Freiburg. Medical Center and Faculty of Medicine)
Maestro-de la Calle, Guillermo (Hospital Universitario 12 de Octubre (Madrid))
Manzur, Adriana (Infectious Diseases. Hospital Rawson)
Marin, Jorge Iván (Critical Care and Clinical Microbiology Department. Universidad de Manizales)
Márquez-Gómez, Ignacio (Hospital Regional Universitario de Málaga)
Martín-Dávila, Pilar (Hospital Universitario Ramón y Cajal (Madrid))
Mikulska, Malgorzata (Division of Infectious Diseases. University of Genoa (DISSAL) and Ospedale Policlinico San Martino)
Montejo, José Miguel (Hospital Universitario de Cruces (Barakaldo, País Basc))
Montero, María Milagro (Institut Hospital del Mar d'Investigacions Mèdiques)
Morales, Hugo Manuel Paz (Infectious Diseases Department. Hospital Erasto Gaertner)
Morales Fariña, Inmaculada (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Novo, Andrés (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Oltolini, Chiara (IRCCS San Raffaele Scientific Institute (Milà, Itàlia). Unit of Infectious and Tropical Diseases)
Peghin, Maddalena (Infectious Diseases Clinic. Department of Medicine. University of Udine and Azienda Sanitaria Universitaria Integrata)
Del Pozo, Jose Luis (Clínica Universidad de Navarra)
Puerta-Alcalde, Pedro (Hospital Clínic i Provincial de Barcelona)
Ruiz-Camps, Isabel (Hospital Universitari Vall d'Hebron)
Sipahi, Oguz Resat (Faculty of Medicine. Ege University)
Tilley, Robert (University Hospitals Plymouth NHS Trust (Regne Unit))
Yáñez, Lucrecia (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Gomes, Marisa Z. R (Hospital Federal Servidores Do Estado. Ministerio da Saúde)
Carratalà, Jordi (Spanish Network for Research in Infectious Diseases)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	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.
Ajuts:	Ministerio de Economía y Competitividad RD16-0016-0001
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	BMJ open, Vol. 9 Núm. 5 (january 2019) , p. e025744, ISSN 2044-6055

DOI: 10.1136/bmjopen-2018-025744
PMID: 31129580

6 p, 338.8 KB

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