Treatment of patients with febrile neutropenia (FN) attending Emergency Departments (EDs) relies on rapid antibiotic initiation in order to control a presumed infection. The choice of initial antibiotics is empirical and depends on patient's prior colonization or infection by multi-drug resistant pathogens (MDRPs) and risk stratification. Stratification of high-risk patients needing broad-spectrum antibiotics is debated. Thus, for non-specialist physicians, this choice may be challenging, leading to inappropriate initial antimicrobial regimens, potential risks for the patient and higher costs. Furthermore, international guidelines recommended to develop antibiotic stewardship programs and promoted an initial strategy based on escalation or de-escalation approaches, with early reassessment depending on patients' clinical course and microbiological results. Nevertheless, this interesting strategy may increase the level of complexity for the choice of the initial antibiotic regimen by non-specialist emergency physicians who are often the first prescribers in this context. We developed an interactive computerized decision support app (CDSA) for initial antibiotic prescription and early revaluation in patients with FN. The first goal of this app is to assist non-specialized physicians in choosing initial antimicrobial regimen for patients with FN when they attend EDs. It uses an interactive algorithm based on international guidelines that takes into account patients' medical history and characteristics. Secondly, the app is also designed to propose an algorithm of antibiotic revaluation at day 3-4 for hospitalized patients, depending on patient clinical course, and biological and microbiological results. The revaluation suggests antimicrobial modification (escalation or de-escalation) or discontinuation and stopping rules with recommended duration of therapy also based on international guidelines. We hypothesize that such a CDSA may improve the adherence to guidelines for the choice of initial antibiotic regimen for FN in the ED, favour early antibiotic reassessment for hospitalized patients, both decreasing the risk of treatment failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
540
The choice of the initial antibiotic regimen will be let to the discretion of the emergency physician
Implementation of an Computerized Decision support app (CDSA) : physician will use this app to help him in the antibiotic choice. This app is an interactive algorithm based on international guidelines that takes into account patients' medical history and characteristics. Secondly, the application is also designed to propose an algorithm of antibiotic revaluation at day 3 for hospitalized patients, depending on patient clinical course, and biological and microbiological results. The revaluation suggests antimicrobial modification (escalation or de-escalation) or discontinuation and stopping rules with recommended duration of therapy also based on international guidelines.
Treatment failure
Treatment failure will be defined by any escalation of the assigned empirical initial antibiotic treatment (e.g. adjunction of aminoglycoside, glycopeptide or other anti-gram positive or any broadening of the beta-lactam spectrum) during the 7 days following inclusion, in relation with at least one of the following reasons: * microbiologic reason; * clinical progression of the presumed infection defined as persistence, recurrence or worsening of clinical signs or symptoms of presenting infection (e.g. death due to the initial infection, occurrence of sepsis or septic shock, need for oxygen therapy (or increasing oxygen flow) or mechanical or non-invasive ventilation in case of pneumonia, neurological deterioration in case of central nervous system infection). Treatment failure outcome will be reviewed by at least 2 experts blinded to the arm.
Time frame: 7 days following inclusion
Number of initial antibiotic regimen adhering to the international guidelines
Time frame: at inclusion
Time to antibiotic initiation from patient triage at the emergency department (minutes)
Time frame: at inclusion
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
Time frame: at 3 days
Number of antimicrobial spectrum reductions
Time frame: at 3 days
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
Time frame: at inclusion
Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
Time frame: up to 3 months
Number of super-infections
A super-infection will be defined as new, persistent or worsening symptoms and/or signs of infection associated with the isolation of a new pathogen (different, or different susceptibilities) or the development of a new site of infection;
Time frame: up to 3 months
Number of super-infections due to clostridium difficile
Time frame: up to 3 months
Number of colonization
Colonization will be defined as isolation during or after therapy of Gram-negative bacteria resistant to the beta-lactam included in the empirical regimen, without symptoms or signs of infection
Time frame: up to 3 months
Number of episodes of nephrotoxicity
Time frame: up to 3 months
Number of episodes of other toxicities
Toxicities will be defined according to the common terminology criteria for adverse events
Time frame: up to 3 months
Occurrence of any complication during hospital stay or follow-up
Time frame: up to 3 months
Number of re-hospitalizations due to a complication related to the initial infection
Time frame: within 7 days of discharge
Antibiotic treatment duration
Time frame: up to 3 months
Length of hospital stay
Time frame: up to 3 months
Total 3-month costs
Time frame: at 3 months
Number of deaths related to infection
Death related to infections will be defined according to the physician in charge of the patient
Time frame: at 3 months
Number of in-hospital death
Time frame: up to 3 months
Survival status
Time frame: at day 90
Health related quality of life
Quality of life will be assessed using the EQ5D5L scale. The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS). The descriptive system has five dimensions. Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life. The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
Time frame: at inclusion
Health related quality of life.
Quality of life will be assessed using the EQ5D5L scale. The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS). The descriptive system has five dimensions. Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life. The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
Time frame: at day 30
Health related quality of life.
Quality of life will be assessed using the EQ5D5L scale. The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS). The descriptive system has five dimensions. Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life. The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
Time frame: at 3 months
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