HCAPPED I: HCAP-Pcr in Emergency Department

Recruiting

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

• Registration Number: NCT06506617
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-07-07
• Study Completion: 2026-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluate the impact of early use of multiplex PCR	perioperatively/periprocedurally	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda ospedaliero universitaria careggi; 🇮🇹 Florence, Tuscany/Italy, Italy