Clinical trial NCT05206006: Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure.
Official title: Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. A Randomized Cluster-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Febrile Neutropenia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedged design
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* refusal to participate;
* prior inclusion in the study for a previous episode of FN;
* 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).

Primary outcomes:
measure: Treatment failure
timeFrame: 7 days following inclusion
Secondary outcomes:
measure: Number of initial antibiotic regimen adhering to the international guidelines
timeFrame: at inclusion
measure: Time to antibiotic initiation from patient triage at the emergency department (minutes)
timeFrame: at inclusion
measure: Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
timeFrame: at 3 days
measure: Number of antimicrobial spectrum reductions
timeFrame: at 3 days
measure: Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
timeFrame: at inclusion
measure: Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
timeFrame: up to 3 months
measure: Number of super-infections
timeFrame: up to 3 months
measure: Number of super-infections due to clostridium difficile
timeFrame: up to 3 months
measure: Number of colonization
timeFrame: up to 3 months
measure: Number of episodes of nephrotoxicity
timeFrame: up to 3 months
measure: Number of episodes of other toxicities
timeFrame: up to 3 months
measure: Occurrence of any complication during hospital stay or follow-up
timeFrame: up to 3 months
measure: Number of re-hospitalizations due to a complication related to the initial infection
timeFrame: within 7 days of discharge
measure: Antibiotic treatment duration
timeFrame: up to 3 months
measure: Length of hospital stay
timeFrame: up to 3 months
measure: Total 3-month costs
timeFrame: at 3 months
measure: Number of deaths related to infection
timeFrame: at 3 months
measure: Number of in-hospital death
timeFrame: up to 3 months
measure: Survival status
timeFrame: at day 90
measure: Health related quality of life
timeFrame: at inclusion
measure: Health related quality of life.
timeFrame: at day 30
measure: Health related quality of life.
timeFrame: at 3 months
Other outcomes:
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