Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. (ANTIBIONEED)
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Olivier Peyrony
- Número de teléfono: +33142494804
- Correo electrónico: olivier.peyrony@aphp.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Control Group
As routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician.
|
The choice of the initial antibiotic regimen will be let to the discretion of the emergency physician
|
|
Experimental: computerized decision support app (CDSA) Group
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment failure
Periodo de tiempo: 7 days following inclusion
|
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:
|
7 days following inclusion
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of initial antibiotic regimen adhering to the international guidelines
Periodo de tiempo: at inclusion
|
at inclusion
|
|
|
Time to antibiotic initiation from patient triage at the emergency department (minutes)
Periodo de tiempo: at inclusion
|
at inclusion
|
|
|
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
Periodo de tiempo: at 3 days
|
at 3 days
|
|
|
Number of antimicrobial spectrum reductions
Periodo de tiempo: at 3 days
|
at 3 days
|
|
|
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
Periodo de tiempo: at inclusion
|
at inclusion
|
|
|
Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Number of super-infections
Periodo de tiempo: up to 3 months
|
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;
|
up to 3 months
|
|
Number of super-infections due to clostridium difficile
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Number of colonization
Periodo de tiempo: up to 3 months
|
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
|
up to 3 months
|
|
Number of episodes of nephrotoxicity
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Number of episodes of other toxicities
Periodo de tiempo: up to 3 months
|
Toxicities will be defined according to the common terminology criteria for adverse events
|
up to 3 months
|
|
Occurrence of any complication during hospital stay or follow-up
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Number of re-hospitalizations due to a complication related to the initial infection
Periodo de tiempo: within 7 days of discharge
|
within 7 days of discharge
|
|
|
Antibiotic treatment duration
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Length of hospital stay
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Total 3-month costs
Periodo de tiempo: at 3 months
|
at 3 months
|
|
|
Number of deaths related to infection
Periodo de tiempo: at 3 months
|
Death related to infections will be defined according to the physician in charge of the patient
|
at 3 months
|
|
Number of in-hospital death
Periodo de tiempo: up to 3 months
|
up to 3 months
|
|
|
Survival status
Periodo de tiempo: at day 90
|
at day 90
|
|
|
Health related quality of life
Periodo de tiempo: at inclusion
|
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.
|
at inclusion
|
|
Health related quality of life.
Periodo de tiempo: at day 30
|
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.
|
at day 30
|
|
Health related quality of life.
Periodo de tiempo: at 3 months
|
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.
|
at 3 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP210357
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .