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Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial.INTRODUCTION Finding therapeutic alternatives to carbapenems in infections caused by extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) is imperative. Although fosfomycin was discovered more than 40 years ago, it was not investigated in accordance with current standards and so is not used in clinical practice except in desperate situations. It is one of the so-called neglected antibiotics of high potential interest for the future. METHODS AND ANALYSIS The main objective of this project is to demonstrate the clinical non-inferiority of intravenous fosfomycin with regard to meropenem for treating bacteraemic urinary tract infections (UTI) caused by ESBL-EC. This is a 'real practice' multicentre, open-label, phase III randomised controlled trial, designed to compare the clinical and microbiological efficacy, and safety of intravenous fosfomycin (4 g/6 h) and meropenem (1 g/8 h) as targeted therapy for this infection; a change to oral therapy is permitted after 5 days in both arms, in accordance with predetermined options. The study design follows the latest recommendations for designing trials investigating new options for multidrug-resistant bacteria. Secondary objectives include the study of fosfomycin concentrations in plasma and the impact of both drugs on intestinal colonisation by multidrug-resistant Gram-negative bacilli. ETHICS AND DISSEMINATION Ethical approval was obtained from the Andalusian Coordinating Institutional Review Board (IRB) for Biomedical Research (Referral Ethics Committee), which obtained approval from the local ethics committees at all participating sites in Spain (22 sites). Data will be presented at international conferences and published in peer-reviewed journals. DISCUSSION This project is proposed as an initial step in the investigation of an orphan antimicrobial of low cost with high potential as a therapeutic alternative in common infections such as UTI in selected patients. These results may have a major impact on the use of antibiotics and the development of new projects with this drug, whether as monotherapy or combination therapy. TRIAL REGISTRATION NUMBER NCT02142751. EudraCT no: 2013-002922-21. Protocol V.1.1 dated 14 March 2014.
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How medical students think about ethical issues.Although bioethics has become an established part of medical school curricula, relatively little is known about how students apply didactic material to clinical problem-solving situations.Each of 92 second-year students (54 men and 38 women) at the University of California, Irvine, College of Medicine in 1991-92 wrote a paper identifying and attempting to resolve a clinical ethical dilemma of his or her choice. The papers were then coded for content, use of ethical theories and principles, degree of resolution, and level of personal orientation (i.e., evidence of personal involvement in the dilemmas). Data were analyzed by student sex and age, using chi-square tests of significance and correlational analysis.The students had no difficulty in identifying a range of ethical dilemma. Most students appeared to have understood and become familiar with the major ethical theories and principles currently in use, and to have employed them correctly. A majority of the students were able to successfully resolve their ethical dilemmas. Differences between the men and the women students were found regarding choice of topic, ethical principles used (p = .03), and level of personal orientation (p < .01).The women tended to be interested in issues involving broad social perspectives; to favor arguments emphasizing the rights of patients and families; and to incorporate personal responses, as well as abstract theories, in their assays. The men tended to be interested in issues involving personal control, authority, and responsibility; to advocate utilitarian, cost-containment thinking, and to rely exclusively on abstract, logical arguments. Further research should determine whether these differences can be identified in actual clinical decision making, and whether the differences have implications for the nature or quality of clinical decisions.
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How medical students think about ethical issues.Although bioethics has become an established part of medical school curricula, relatively little is known about how students apply didactic material to clinical problem-solving situations. Each of 92 second-year students (54 men and 38 women) at the University of California, Irvine, College of Medicine in 1991-92 wrote a paper identifying and attempting to resolve a clinical ethical dilemma of his or her choice. The papers were then coded for content, use of ethical theories and principles, degree of resolution, and level of personal orientation (i.e., evidence of personal involvement in the dilemmas). Data were analyzed by student sex and age, using chi-square tests of significance and correlational analysis. The students had no difficulty in identifying a range of ethical dilemma. Most students appeared to have understood and become familiar with the major ethical theories and principles currently in use, and to have employed them correctly. A majority of the students were able to successfully resolve their ethical dilemmas. Differences between the men and the women students were found regarding choice of topic, ethical principles used (p = .03), and level of personal orientation (p < .01). The women tended to be interested in issues involving broad social perspectives; to favor arguments emphasizing the rights of patients and families; and to incorporate personal responses, as well as abstract theories, in their assays. The men tended to be interested in issues involving personal control, authority, and responsibility; to advocate utilitarian, cost-containment thinking, and to rely exclusively on abstract, logical arguments. Further research should determine whether these differences can be identified in actual clinical decision making, and whether the differences have implications for the nature or quality of clinical decisions.