HCAPPED I: HCAP-Pcr in Emergency Department
NCT Number: NCT06506617
Acronym: HCAPPED-I
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pneumonia|Bronchoalveolar Lavage|Antimicrobial Treatment|Sputum
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 93
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-07
Completion Date: 2026-01-07
Locations: Azienda ospedaliero universitaria careggi, Florence, Tuscany/Italy, 50122, Italy

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\&gt;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\&#39;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.

Primary Outcome Measures: 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: 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