HCAPPED I: HCAP-Pcr in Emergency Department

NCT06506617 | Recruiting

• 1 other identifier: CEAVC 26198_oss
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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\>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.

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

Outcome Measures

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.

  perioperatively/periprocedurally

Secondary Outcomes (9)

• Time to Antibiotic Escalation or De-escalation

  up to 3 months

• Length of Hospital Stay

  up to 3 months

• Need for Escalation of Supportive Therapy:

  up to 3 months

• Duration of Antibiotic Therapy:

  up to 3 months

• De-escalation of Antibiotic Therapy

  7 days from admission

Study Arms (1)

PCR multiplex (BIOFIRE® FILMARRAY® Pneumonia plus Panel)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda ospedaliero universitaria careggi

Florence, Tuscany/Italy, 50122, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

BAL, BAS, ETA

MeSH Terms

Conditions

Pneumonia; De Lange Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Pelagatti Lorenzo, Dr

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pelagatti Lorenzo, Dr

CONTACT

+393385917317; pelagattil@aou-careggi.toscana.it

Pelagatti Lorenzo, Dr

CONTACT

+390557947088; lorenzo.pelagatti@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: June 7, 2024
• Primary Completion: July 7, 2025
• Study Completion: January 7, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

IT (1)