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 A Infectious Diseases Department, Bellvitge University Hospital, IDIBELL, University of Barcelona, Spain.
- Gudiol C Infectious Diseases Department, Bellvitge University Hospital, IDIBELL, University of Barcelona, Spain.
- Parody R Haematology Department, Institut Català d' Oncologia (ICO)-Hospital Duran i Reynals, IDIBELL, Barcelona, Spain.
- Tebe C Statistics Advisory Service, Institute of Biomedical Research of Bellvitge, Rovira i Virgili University, 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.
- Bote A Infectious Diseases Department, Parc Taulí University Hospital, Sabadell, Barcelona, Spain.
- Brunel AS Infectious Diseases Department, Department of Medicine, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
- Calik S Department of Infectious Diseases and Clinical Microbiology, University of Health Science Izmir Bozyaka Training and Research Hospital, Izmir, Turkey.
- Drgona L Oncohematology Department, Comenius University and National Cancer Institute, Bratislava, Slovakia.
- García E Haematology Department, Reina Sofía University Hospital-IMIBIC-UCO, Córdoba, Spain.
- Hemmati P Department of Haematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Academic Teaching Hospital of Charité University Medical School, Berlin, Germany.
- Herrera F Infectious Diseases Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
- Ibrahim KY Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina da Universidade de São Paulo, Brazil.
- Isler B Department of Infectious Diseases and Clinical Microbiology, Istanbul Education and Research Hospital, Istanbul, Turkey.
- Kanj S Infectious Diseases Division, American University of Beirut Medical Center, Beirut, Lebanon.
- Kern W Division of Infectious Diseases, Department of Medicine II, University of Freiburg, Medical Center and Faculty of Medicine, Freiburg, Germany.
- Maestro de la Calle G Infectious Diseases Unit, Instituto de Investigación Hospital "12 de Octubre" (i+12), " 12 de Octubre" University Hospital, School of Medicine, Universidad Complutense, Madrid, Spain.
- Manzur A Infectious Diseases, Hospital Rawson, San Juan, Argentina.
- Marin JI Infectious Diseases and Clinical Microbiology Department, Clínica Maraya, Pereira, Colombia.
- Márquez-Gómez I Infectious Diseases Department, Hospital Regional Universitario de Málaga, Málaga, Spain.
- Martín-Dávila P Infectious Diseases Department, Ramon y Cajal Hospital, Madrid, Spain.
- Mikulska M Division of Infectious Diseases, University of Genoa (DISSAL) and Ospedale Policlinico San Martino, Genova, Italy.
- Montejo JM Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain.
- Montero M Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain.
- Morales HMP Infectious Diseases Department, Hospital Erasto Gaertner, Curitiba, Brazil.
- Morales I Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain.
- Novo A Haematology Department, Son Espases University Hospital, Palma de Mallorca, Spain.
- Oltolini C Unit of Infectious and Tropical Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
- Peghin M Infectious Diseases Clinic, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata, Udine, Italy.
- Del Pozo JL Infectious Diseases and Microbiology Unit, Navarra University Clinic, Pamplona, Spain.
- Puerta-Alcalde P Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain.
- Ruiz-Camps I Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain.
- Sipahi OR Faculty of Medicine, Ege University, Izmir, Turkey.
- Tilley R Microbiology Department, University Hospitals Plymouth NHS Trust, UK.
- Yáñez L Haematology Department, Marques de Valdecilla University Hospital, Santander, Spain.
- Gomes MZR Instituto Oswaldo Cruz, Fundaçao Oswaldo Cruz, Rio de Janeiro, Brazil.
- Carratalà J Infectious Diseases Department, Bellvitge University Hospital, IDIBELL, University of Barcelona, Spain.
- 2019-05-27
Published in:
- BMJ open. - 2019
bacteraemia
bloodstream infection
multidrug-resistant
neutropenia
onco-haematological patients
pseudomonas aeruginosa
Anti-Bacterial Agents
Bacteremia
Cephalosporins
Drug Resistance, Multiple, Bacterial
Humans
International Cooperation
Logistic Models
Multicenter Studies as Topic
Neoplasms
Neutropenia
Observational Studies as Topic
Pseudomonas Infections
Pseudomonas aeruginosa
Research Design
Retrospective Studies
Tazobactam
Time Factors
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1136/bmjopen-2018-025744
- PMID 31129580
- Persistent URL
- https://sonar.ch/global/documents/35423
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