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Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. (ANTIBIONEED)

24 gennaio 2022 aggiornato da: Assistance Publique - Hôpitaux de Paris

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

540

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Control Group
As routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician.
Altro: routine care
The choice of the initial antibiotic regimen will be let to the discretion of the emergency physician
Sperimentale: computerized decision support app (CDSA) Group
Altro: Computerized Decision support app (CDSA)
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment failure
Lasso di tempo: 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:

  • 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of initial antibiotic regimen adhering to the international guidelines
Lasso di tempo: at inclusion
at inclusion
Time to antibiotic initiation from patient triage at the emergency department (minutes)
Lasso di tempo: at inclusion
at inclusion
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
Lasso di tempo: at 3 days
at 3 days
Number of antimicrobial spectrum reductions
Lasso di tempo: at 3 days
at 3 days
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
Lasso di tempo: at inclusion
at inclusion
Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
Lasso di tempo: up to 3 months
up to 3 months
Number of super-infections
Lasso di tempo: 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
Lasso di tempo: up to 3 months
up to 3 months
Number of colonization
Lasso di tempo: 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
Lasso di tempo: up to 3 months
up to 3 months
Number of episodes of other toxicities
Lasso di tempo: 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
Lasso di tempo: up to 3 months
up to 3 months
Number of re-hospitalizations due to a complication related to the initial infection
Lasso di tempo: within 7 days of discharge
within 7 days of discharge
Antibiotic treatment duration
Lasso di tempo: up to 3 months
up to 3 months
Length of hospital stay
Lasso di tempo: up to 3 months
up to 3 months
Total 3-month costs
Lasso di tempo: at 3 months
at 3 months
Number of deaths related to infection
Lasso di tempo: 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
Lasso di tempo: up to 3 months
up to 3 months
Survival status
Lasso di tempo: at day 90
at day 90
Health related quality of life
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

14 febbraio 2022

Completamento primario (Anticipato)

21 marzo 2023

Completamento dello studio (Anticipato)

21 giugno 2023

Date di iscrizione allo studio

Primo inviato

24 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

24 gennaio 2022

Primo Inserito (Effettivo)

25 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP210357

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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