Clinical trial NCT06506617: HCAPPED I: HCAP-Pcr in Emergency Department
Official title: HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Bronchoalveolar Lavage
Antimicrobial Treatment
Sputum
Keywords: Bronchoalveolar lavage
Endotracheal Aspirate
Antimicrobial treatment
pneumonia
hcap
pcr multiplex
moleculas syndromic panel
bal
bas
eta
sputum
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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\&gt;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\&#39;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: Inclusion Criteria:

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. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.

Additionally, patients must meet at least one of the following criteria:

* Need for high-flow oxygen therapy (VM35 or FiO2 \&gt;35%, Reservoir, HFNC, NIV, CPAP)
* Intubation (IOT)
* SOFA score ≥2 or PSI score \&gt;85 (age 75 + IR)
* Horowitz index (PaO2/FiO2) \&lt; 200

Exclusion Criteria:

* Lack of consent
* Age under 18 or over 90
* Pregnancy
* Life expectancy less than 3 months
* Hospital admission \&gt;48 hours (hospital-acquired pneumonia - HAP)
* Rankin score ≥ 5
* Community-acquired pneumonia (CAP)

Primary outcomes:
measure: evaluate the impact of early use of multiplex PCR
timeFrame: perioperatively/periprocedurally
Secondary outcomes:
measure: Time to Antibiotic Escalation or De-escalation
timeFrame: up to 3 months
measure: Length of Hospital Stay
timeFrame: up to 3 months
measure: Need for Escalation of Supportive Therapy:
timeFrame: up to 3 months
measure: Duration of Antibiotic Therapy:
timeFrame: up to 3 months
measure: De-escalation of Antibiotic Therapy
timeFrame: 7 days from admission
measure: Escalation of Antibiotic Therapy
timeFrame: 7 days from admission
measure: Identification of HCAP Etiology
timeFrame: 7 days from admission
measure: In-hospital Mortality
timeFrame: up to 3 months
measure: 30-day Mortality and Readmission
timeFrame: 30 days from discharge
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda ospedaliero universitaria careggi
state: Tuscany/Italy
Study officials:
affiliation: AOU Careggi
name: Pelagatti Lorenzo, Dr
role: PRINCIPAL_INVESTIGATOR
References: