Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure.
ANTIBIONEED
1 other identifier
interventional
540
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedJanuary 25, 2022
January 1, 2022
1.1 years
January 24, 2022
January 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
7 days following inclusion
Secondary Outcomes (22)
Number of initial antibiotic regimen adhering to the international guidelines
at inclusion
Time to antibiotic initiation from patient triage at the emergency department (minutes)
at inclusion
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
at 3 days
Number of antimicrobial spectrum reductions
at 3 days
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
at inclusion
- +17 more secondary outcomes
Study Arms (2)
Control Group
OTHERAs routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician.
computerized decision support app (CDSA) Group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- age ≥ 18 years;
- reported or observed fever at arrival at the ED (≥38.3° C on one occasion or ≥38°C on two or more occasions within 1 h);
- chemotherapy-induced neutropenia (absolute neutrophil count ≤500/mm3 or ≤1000/mm3 and anticipated to decrease to fewer than 500/mm3 within 24 to 48 h).
You may not qualify if:
- refusal to participate;
- any intravenous antibiotic administration during the preceding 72 h;
- renal failure requiring renal replacement therapy or with an estimated creatinine clearance of less than 20 ml/min;
- palliative status with life expectancy of less than three days;
- pregnancy, absence of health insurance, mental deficiency or inability to understand informed consent, no French speaking;
- patient with a microbiological documented infection when arriving at the ED (e.g. positive blood culture).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2022
First Posted
January 25, 2022
Study Start
February 14, 2022
Primary Completion
March 21, 2023
Study Completion
June 21, 2023
Last Updated
January 25, 2022
Record last verified: 2022-01