HCAPPED I: HCAP-Pcr in Emergency Department (HCAPPED-I)

Azienda Ospedaliero-Universitaria Careggi

Status: Enrolling

Conditions: Antimicrobial Treatment; Sputum; Pneumonia; Bronchoalveolar Lavage

Study type: Observational

Funder types: Other

Identifiers

NCT06506617

CEAVC 26198_oss

Details and patient eligibility

About

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.

Enrollment: 93 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 >35%, Reservoir, HFNC, NIV, CPAP)
• Intubation (IOT)
• SOFA score ≥2 or PSI score >85 (age 75 + IR)
• Horowitz index (PaO2/FiO2) < 200

Exclusion criteria

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

Trial design

93 participants in 1 patient group

PCR multiplex (BIOFIRE® FILMARRAY® Pneumonia plus Panel)

Description:

The study seeks to assess the utility of molecular diagnostic tests in the emergency department for the microbiological etiological diagnosis of healthcare-associated pneumonia (HCAP). In clinical practice, patients with respiratory and infectious symptoms undergo blood sample collection for blood gas, chemical-physical, and culture analyses, urine samples for urinary antigen testing, and imaging diagnostics (X-ray, CT, ultrasound). Due to local infection control and surveillance measures, all patients with respiratory symptoms undergo a nasopharyngeal antigen test for SARS-CoV-2 as part of standard clinical practice. After completing the diagnostic work-up and diagnosing HCAP pneumonia, endobronchial samples are typically collected for multiplex PCR testing (BIOFIRE® FILMARRAY® Pneumonia plus Panel). Patients from whom these samples are collected are those needing high-flow oxygen therapy (VM35 or FiO2 higher, Reservoir, HFNC, NIV, CPAP), undergoing IOT, SOFA ≥2, PaO2/FiO2 \< 200, o