NCT06506617 HCAPPED I: HCAP-Pcr in Emergency Department
| NCT ID | NCT06506617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi |
| Condition | Pneumonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 93 participants |
| Start Date | 2024-06-07 |
| Primary Completion | 2025-07-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 93 participants in total. It began in 2024-06-07 with a primary completion date of 2025-07-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Pelagatti Lorenzo, Dr
PRINCIPAL INVESTIGATOR
AOU Careggi
Frequently Asked Questions
Who can join the NCT06506617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506617 currently recruiting?
Yes, NCT06506617 is actively recruiting participants. Contact the research team at pelagattil@aou-careggi.toscana.it for enrollment information.
Where is the NCT06506617 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT06506617 clinical trial?
NCT06506617 is sponsored by Azienda Ospedaliero-Universitaria Careggi. The principal investigator is Pelagatti Lorenzo, Dr at AOU Careggi. The trial plans to enroll 93 participants.