HCAPPED I: HCAP-Pcr in Emergency Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria Careggi
About this trial
Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.
A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.
The use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO\>2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician\'s discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.
Duration of patient enrollment: 1 year. Duration of the study: 1.5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Need for high-flow oxygen therapy (VM35 or FiO2 >35%, Reservoir, HFNC, NIV, CPAP)
Intubation (IOT)
SOFA score ≥2 or PSI score >85 (age 75 + IR)
Horowitz index (PaO2/FiO2) < 200
Disqualifiers
Lack of consent
Age under 18 or over 90
Pregnancy
Life expectancy less than 3 months
Trial population
All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. A patient is considered to have HCAP if they meet any of the following conditions: Hospitalized in an acute care hospital for two or more days within 90 days of symptom onset Residing in a nursing home or long-term care facility Received intravenous antibiotic therapy, chemotherapy, or wound care within the past 30 days Attended a hospital or hemodialysis clinic within the past 30 days for medical reasons, visits, or day services
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
93 Participants
are grouped into 1 trial groupGroup A: PCR multiplex (BIOFIRE® FILMARRAY® Pneumonia plus Panel)
Trial outcomes
Primary outcomes
1
evaluate the impact of early use of multiplex PCR
The primary objective of the study is to evaluate the impact of early use of multiplex PCR on empirical antibiotic therapy. This will be measured by considering the percentage of cases in which the use of multiplex PCR alters the therapy ('escalation' and 'de-escalation') compared to local empirical antibiotic therapy guidelines within 24 hours of hospital admission.
Time frame
perioperatively/periprocedurallySecondary outcomes
1
Time to Antibiotic Escalation or De-escalation
Measure the time from hospital admission to the escalation or de-escalation of antibiotic therapy.
Time frame
up to 3 months2
Length of Hospital Stay
Assess the total duration of the hospital stay.
Time frame
up to 3 months3
Need for Escalation of Supportive Therapy:
Evaluate the necessity for increased supportive therapy, defined as: a) Need for invasive or non-invasive ventilation b) Transfer to a higher level of care c) In-hospital mortality from any cause (complicated course)
Time frame
up to 3 months4
Duration of Antibiotic Therapy:
Track the length of time antibiotics are administered.
Time frame
up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov