Febrile NeutropeniaANTIBIONEEDNCT05206006
Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure.
A study testing routine care and Computerized Decision support app (CDSA) in people with Febrile Neutropenia, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- routine care and Computerized Decision support app (CDSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2022to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Febrile Neutropenia
- Being tested
- routine care, Computerized Decision support app (CDSA)
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine careOther
The choice of the initial antibiotic regimen will be let to the discretion of the emergency physician
Computerized Decision support app (CDSA)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | As routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician. Receives: Other: routine care |
| computerized decision support app (CDSA) Group | Experimental | Not described Receives: Other: Computerized Decision support app (CDSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days following inclusion
Secondary outcomes (22)
Number of initial antibiotic regimen adhering to the international guidelines
Measured: at inclusion
Time to antibiotic initiation from patient triage at the emergency department (minutes)
Measured: at inclusion
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
Measured: at 3 days
Number of antimicrobial spectrum reductions
Measured: at 3 days
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
Measured: at inclusion
Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
Measured: 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;
Measured: up to 3 months
Number of super-infections due to clostridium difficile
Measured: 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
Measured: up to 3 months
Number of episodes of nephrotoxicity
Measured: up to 3 months
Number of episodes of other toxicities
Toxicities will be defined according to the common terminology criteria for adverse events
Measured: up to 3 months
Occurrence of any complication during hospital stay or follow-up
Measured: up to 3 months
Number of re-hospitalizations due to a complication related to the initial infection
Measured: within 7 days of discharge
Antibiotic treatment duration
Measured: up to 3 months
Length of hospital stay
Measured: up to 3 months
Total 3-month costs
Measured: 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
Measured: at 3 months
Number of in-hospital death
Measured: up to 3 months
Survival status
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start14 Feb 2022 (estimated)
- Primary completion21 Mar 2023 (estimated)
- Study completion21 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedged design
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206006
- Sponsor's protocol ID
- APHP210357
- Acronym
- ANTIBIONEED
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05206006
- Acronym / sponsor ID
- ANTIBIONEED / APHP210357
- Conditions
- Febrile Neutropenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Feb 2022 (estimated)
- Primary completion
- 21 Mar 2023 (estimated)
- Study completion
- 21 Jun 2023 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedged design
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: routine careAs 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 | Experimental | Other: Computerized Decision support app (CDSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine careThe choice of the initial antibiotic regimen will be let to the discretion of the emergency physician | Other | Control Group |
| 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. | Other | computerized decision support app (CDSA) Group |
Primary outcome
Treatment failure
Time frame: 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.
22 secondary outcomes
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
Time frame: up to 3 months
Number of super-infections due to clostridium difficile
Time frame: up to 3 months
Number of colonization
Time frame: up to 3 months
Number of episodes of nephrotoxicity
Time frame: up to 3 months
Number of episodes of other toxicities
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
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
Time frame: at inclusion
Health related quality of life.
Time frame: at day 30
Health related quality of life.
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing routine care and Computerized Decision support app (CDSA) in people with Febrile Neutropenia, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Peyrony (+33142494804, olivier.peyrony@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 7 days following inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.