HCAPPED I: HCAP-Pcr in Emergency Department

Azienda Ospedaliero-Universitaria Careggi93 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pneumonia Bronchoalveolar Lavage Antimicrobial Treatment Sputum

Eligibility

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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/periprocedurally

Secondary Outcomes

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 months

Length of Hospital Stay

Assess the total duration of the hospital stay.

Time frame: 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)

Time frame: up to 3 months

Duration of Antibiotic Therapy:

Track the length of time antibiotics are administered.

Time frame: 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.

Time frame: 7 days from admission

Escalation of Antibiotic Therapy

Assess the escalation of antibiotic therapy within the first 7 days of inclusion in the study.

Time frame: 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.

Time frame: 7 days from admission

In-hospital Mortality

Measure in-hospital mortality rates for pneumonia and all causes.

Time frame: up to 3 months

30-day Mortality and Readmission

Measure mortality rates for pneumonia and all causes, and track readmissions within 30 days.

Time frame: 30 days from discharge

HCAPPED I: HCAP-Pcr in Emergency Department

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts