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

HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Sputum; Antimicrobial Treatment; Bronchoalveolar Lavage

• Study Type: Observational
• Enrollment (Estimated): 93

Contacts and Locations

• Study Contact: Name: Pelagatti Lorenzo, Dr; Phone Number: +393385917317; Email: pelagattil@aou-careggi.toscana.it
• Study Contact Backup: Name: Pelagatti Lorenzo, Dr; Phone Number: +390557947088; Email: lorenzo.pelagatti@unifi.it

Study Locations

• Italy
  • Tuscany/Italy
    • Florence, Tuscany/Italy, Italy, 50122
      • Recruiting
      • Azienda Ospedaliero Universitaria Careggi
      • Contact: Pelagatti Lorenzo, Dr; Phone Number: +39 3385917317; Email: pelagattil@aou-careggi.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Antibiotic Escalation or De-escalation	Measure the time from hospital admission to the escalation or de-escalation of antibiotic therapy.	up to 3 months
Length of Hospital Stay	Assess the total duration of the hospital stay.	up to 3 months
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)	up to 3 months
Duration of Antibiotic Therapy:	Track the length of time antibiotics are administered.	up to 3 months
De-escalation of Antibiotic Therapy	Assess the de-escalation of antibiotic therapy within the first 7 days of inclusion in the study.	7 days from admission
Escalation of Antibiotic Therapy	Assess the escalation of antibiotic therapy within the first 7 days of inclusion in the study.	7 days from admission
Identification of HCAP Etiology	Determine the cause of HCAP within the first 7 days of inclusion using all methods: multiplex PCR, culture tests, antigen detection, and serology.	7 days from admission
In-hospital Mortality	Measure in-hospital mortality rates for pneumonia and all causes.	up to 3 months
30-day Mortality and Readmission	Measure mortality rates for pneumonia and all causes, and track readmissions within 30 days.	30 days from discharge

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Pelagatti Lorenzo, Dr, AOU Careggi

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): July 7, 2025
• Study Completion (Estimated): January 7, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pneumonia; sputum; Bronchoalveolar lavage; Endotracheal Aspirate; Antimicrobial treatment; hcap; pcr multiplex; moleculas syndromic panel; bal; bas; eta
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CEAVC 26198_oss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No