Impact of antibiotic resistance on outcomes of neutropenic cancer patients withPseudomonas aeruginosabacteraemia (IRONIC study): study protocol of a retrospective multicentre international study

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 analysisThis 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 disseminationThe 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.

Clinical Predictive Model of Multidrug Resistance in Neutropenic Cancer Patients with Bloodstream Infection Due to Pseudomonas aeruginosa

“…The number of patients recruited at each center is provided in the supplemental material. The study was conducted in accordance with the STROBE recommendations, and the protocol has been published elsewhere (28).…”

Ethical Aspects of Personalized Research and Management of Systemic Inflammatory Response Syndrome (SIRS) in Children

“…The process of providing research participants with all available details, properly and effectively, is defined as a moral duty which (a) sets an ethical training for doctors involved in clinical studies as a requirement and (b) refines the definition of medical professionalism as comprising ethical competence [16,25] and trained communication skills. A communicative competence should teach doctors to tailor their language and medical information to patient's individual level of health literacy, as well as to that of their families [16], and to respect patient's preferences in the framework of confidentiality [17,23,[26][27][28][29]. Ethically informed medical professionalism is also described in the literature as fundamental to shared decision-making [16,23], which ensures that patients are supported to reach a decision that suits them and the preferences of those involved.…”

“…Trained communication skills have also been defined as the obligation of physicians to act for the benefit of the patient [25,27]. Indeed, the need for qualified agents to provide benefits-i.e., positive beneficence-and to balance benefits, risks and costs, i.e., utility, is the aim of continuing medical education [16,25,27,36,37]; whereas the goal of clinical research is to be twofold, namely reaching a scientific understanding leading to sound clinical interventions and designing a common ground in research for future collection and interpretation of data [15,19,28,35,41,42,[44][45][46][47]. Another major ethical issue germane to ethical research with children, and which has been associated in the literature with the principle of beneficence, is medical paternalism.…”

Comprehensive evaluation of risk factors for the development and complications of chemotherapy-induced febrile neutropenia

“…Bacteriaemia is documented in 20% of FN patients [1]. In the past, there used to be a prevalence of Gram-(G) negative bacteriemia among patients with FN, but in the last few decades the shift has occurred towards G-positive bacteriemia and at the present time the ratio between G-positive and G-negative bacteria is 60:40 [5]. Patients with FN and proven bacteriemia have poorer prognosis, with a mortality rate of 18% (G-negative) and 5% (G-positive) [1].…”

“…Patients with FN and proven bacteriemia have poorer prognosis, with a mortality rate of 18% (G-negative) and 5% (G-positive) [1]. The most common isolated G-positive bacteria are Staphylococcus spp., enterococci, and viridans streptococci, while among G-negative bacteria the most common are Escherichia coli, Klebsiella spp., and Pseudomonas aeuruginosa [5]. Fungal and viral infections in patients with FN are rarely an initial type of infection and are related to prolonged severe neutropenia induced with high-dose chemotherapy regimens such as in hematological malignancies.…”