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734 active trials for Cancer

Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway

Social inequalities in the face of cancer are significant in all countries. They are characterized by higher mortality among people may be in the lower socioeconomic category. The care pathway may also be a source of inequality or accentuate inequalities. Socially vulnerable patients must be provided with appropriate care. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and to take them into account throughout the care process. To meet this need, the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") was designed and conducted by the Centre Hygée at the Lucien Neuwirth Cancer Institute (ICLN) in 2014 and 2015, in partnership with an industrial engineering research laboratory, the DISP ("Décision & Information pour les Systèmes de Production"). Its objective was to develop a tool for systematic screening of social fragility, involving few caregivers and making it possible to identify patients most at risk of social maladjustment. The choice was made to develop a self-administered questionnaire using tablets connected to a neural network. Since its implementation, the deployment of the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") tool at the Lucien Neuwirth Cancer Institute (ICLN) has required several training and awareness-raising activities to strengthen the motivation of the various stakeholders. These same actors have also implemented different strategies to optimize the functioning of the tool. Developed in a specialized institution, this tool must demonstrate, in this second stage of the project, it transferability and it possibilities of implementation in other structures. It is also necessary to evaluate it in terms of it is impact, particularly on the fluidity of care pathways and on the social consequences of the disease.

Start: December 2019
Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock

De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens. Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy. The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy. The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality. The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure. Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms. ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE. To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.

Start: November 2018