Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study
| Autor: | Albasanz-Puig, Adaia, Gudiol, Carlota, Parody, Rocio, Tebe, Cristian, Akova, Murat, Araos, Rafael, Bote, Anna, Brunel, Anne-Sophie, Calik, Sebnem, Drgona, Lubos, Garcia, Estefania, Hemmati, Philipp, Herrera, Fabian, Ibrahim, Karim Yaqub, Isler, Burcu, Kanj, Souha, Kern, Winfried, Maestro de la Calle, Guillermo, Manzur, Adriana, Ivan Marin, Jorge, Marquez-Gomez, Ignacio, Martin-Davila, Pilar, Mikulska, Malgorzata, Montejo, Jose Miguel, Montero, Milagros, Paz Morales, Hugo Manuel, Morales, Isabel, Novo, Andres, Oltolini, Chiara, Peghin, Maddalena, Luis del Pozo, Jose, Puerta-Alcalde, Pedro, Ruiz-Camps, Isabel, Resat Sipahi, Oguz, Tilley, Robert, Yanez, Lucrecia, Ribeiro Gomes, Marisa Zenaide, Carratala, Jordi, Cuervo, Guillermo, Escrihuela-Vidal, Francesc, Tubau, Fe, Rodriguez Arias, Marisol, Merve Ayaz, Caglayan, Munita, Jose, Gasch, Oriol, Capilla, Silvia, Bochud, Pierre-Yves, Manuel, Oriol, Torre-Cisneros, Julian, Tabares, Salvador, Serrano Lopez, Josefina, Maschmeyer, Georg, Torres, Diego, Abdala, Edson, Bittencourt, Driele Peixoto, El Zein, Saeed, Jabbour, Jean-Francois, Bertz, Hartmut, Peyerl-Hoffmann, Gabriele, Lizasoain, Manuel, Maria Aguado, Jose, Clemencia Correa, Lina, Palop, Begona, Fortun, Jesus, Magnasco, Laura, Cespedes, Roberto, Lopez-Soria, Leire, Pablo Horcajada, Juan, Montaguti, Mia Hold, de Cueto, Marina, Rodriguez-Bano, Jesus, Greco, Raffaella, Cichero, Paola, Bassetti, Matteo, Castaldo, Nadia, Sangro del Alcazar, Paloma, Cardozo, Celia, Garcia-Vidal, Carolina, Aguilar-Company, Juan, Larrosa, Nieves, Uyan-Onal, Ayse, Nazli-Zeka, Arzu, Vasconcelos de Freitas, Wania, da Silva Machado, Amanda Aparecida, IRONIC Study Grp |
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| Přispěvatelé: | Instituto de Salud Carlos III, Ministerio de Economía, Industria y Competitividad (España), European Commission, IRONIC study group, 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., Institut Català de la Salut, [Albasanz-Puig A, Gudiol C] Departament de Malalties Infeccioses, Hospital Universitari de Bellvitge, Barcelona, Spain. Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. Universitat de Barcelona, Barcelona, Spain. Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain. [Parody R] Departament d’hematologia, Institut Català d' Oncologia (ICO) Barcelona, Spain. Hospital Duran i Reynals, Barcelona, Spain. . Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. [Tebe C] Servei d’estadística, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. Universitat Rovira i Virgili, Barcelona, Spain. [Akova M] Infectious Diseases Department, Hacettepe University School of Medicine, Ankara, Turkey. [Araos R] Infectious Diseases Department, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Santiago de Chile, Chile. [Ruiz-Camps I] Servei de Malalties Infeccioses, Hospital Universitari Vall d'Hebron, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Ege Üniversitesi |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Microbiological Phenomena::Drug Resistance
Microbial [PHENOMENA AND PROCESSES] Research design infecciones bacterianas y micosis::infecciones bacterianas y micosis::infección::sepsis::bacteriemia [ENFERMEDADES] bacteraemia Time Factors modelos logísticos International Cooperation humanos resistencia a medicamentos Drug Resistance Bacteremia Bacteria::bacterias gramnegativas::bacterias aerobias gramnegativas::bacilos y cocos aerobios gramnegativos::Pseudomonadaceae::Pseudomonas::Pseudomonas aeruginosa [ORGANISMOS] bloodstream infection multidrug-resistant neutropenia onco-haematological patients pseudomonas aeruginosa estudios multicéntricos como asunto Bacterièmia 0302 clinical medicine Bacteria::Gram-Negative Bacteria::Gram-Negative Aerobic Bacteria::Gram-Negative Aerobic Rods and Cocci::Pseudomonadaceae::Pseudomonas::Pseudomonas aeruginosa [ORGANISMS] Drug Resistance Multiple Bacterial Neoplasms Clinical endpoint Onco-haematological patients Multicenter Studies as Topic Multidrug-resistant Microorganismes - Resistència als medicaments Otros calificadores::Otros calificadores::/inmunología [Otros calificadores] 030212 general & internal medicine neoplasias 0303 health sciences Neutropènia fenómenos microbiológicos::farmacorresistencia microbiana [FENÓMENOS Y PROCESOS] Incidence (epidemiology) bacteriemia General Medicine Bacterial Infections and Mycoses::Bacterial Infections and Mycoses::Infection::Sepsis::Bacteremia [DISEASES] Anti-Bacterial Agents Malalts de càncer Observational Studies as Topic Research Design Pseudomonas aeruginosa Ceftolozane antibacterianos medicine.drug medicine.medical_specialty Tazobactam Neutropenia Pseudomones aeruginosa Bloodstream infection 03 medical and health sciences factores de tiempo Other subheadings::Other subheadings::/immunology [Other subheadings] Internal medicine Pseudomonas medicine Humans Pseudomonas Infections Anti-Bacterial Agents/therapeutic use Bacteremia/drug therapy Bacteremia/mortality Cephalosporins/therapeutic use Logistic Models Neoplasms/complications Neutropenia/complications Pseudomonas Infections/drug therapy Pseudomonas aeruginosa/isolation & purification Retrospective Studies Tazobactam/therapeutic use Resistència als medicaments infecciones por Pseudomonas cefalosporinas 030306 microbiology business.industry estudios retrospectivos enfermedades hematológicas y linfáticas::enfermedades hematológicas::trastornos leucocitarios::leucopenia::agranulocitosis::neutropenia [ENFERMEDADES] cooperación internacional Retrospective cohort study Cancer patients medicine.disease Cephalosporins Drug resistance Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia [DISEASES] Bacteraemia Observational study business diseño de la investigación |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona Digital.CSIC. Repositorio Institucional del CSIC instname BMJ open, vol. 9, no. 5, pp. e025744 Recercat. Dipósit de la Recerca de Catalunya Scientia |
| DOI: | 10.1136/bmjopen-2018-025744 |
| Popis: | The IRONIC study group: Cuervo, Guillermo; Escrihuela-Vidal, Francesc; Tubau, Fe; Rodriguez Arias, Marisol; Merve Ayaz, Caglayan; Munita, Jose; Gasch, Oriol; Capilla, Silvia; Bochud, Pierre-Yves; Manuel, Oriol; Torre-Cisneros, Julian; Tabares, Salvador; Serrano Lopez, Josefina; Maschmeyer, Georg; Torres, Diego; Abdala, Edson; Bittencourt, Driele Peixoto; El Zein, Saeed; Jabbour, Jean-Francois; Bertz, Hartmut; Peyerl-Hoffmann, Gabriele; Lizasoain, Manuel; Maria Aguado, Jose; Clemencia Correa, Lina; Palop, Begona; Fortun, Jesus; Magnasco, Laura; Cespedes, Roberto; Lopez-Soria, Leire; Pablo Horcajada, Juan; Montaguti, Mia Hold; de Cueto, Marina; Rodriguez-Bano, Jesus; Greco, Raffaella; Cichero, Paola; Bassetti, Matteo; Castaldo, Nadia; Sangro del Alcazar, Paloma; Cardozo, Celia; Garcia-Vidal, Carolina; Aguilar-Company, Juan; Larrosa, Nieves; Uyan-Onal, Ayse; Nazli-Zeka, Arzu; Vasconcelos de Freitas, Wania; da Silva Machado, Amanda Aparecida [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 oncohaematological 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 multidrugresistant 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 peerreviewed publications. This study was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001) and co-financed by European Development Regional Fund “A way to achieve Europe”, Operative Programme Intelligent Growth 2014‐2020. |
| Databáze: | OpenAIRE |
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