Using molecular panels to improve pneumonia treatment in emergency patients

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

This study is testing if using special tests to quickly identify the right antibiotics can help improve treatment for patients with severe pneumonia in the emergency department.

Quick facts

• Study type: Observational
• Enrollment: 93 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero-Universitaria Careggi (other)
• Locations: 1 site (Florence, Tuscany/Italy)
• Trial ID: NCT06506617 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with healthcare-associated pneumonia (HCAP) who require bronchoalveolar lavage in the emergency department. It aims to evaluate the early use of syndromic molecular panels to guide antibiotic therapy in patients with severe HCAP, particularly those at risk for multidrug-resistant pathogens. The study will involve a single cohort of patients without a control group, assessing the impact of this diagnostic tool on treatment management. The goal is to determine if early intervention can enhance patient outcomes in this critical setting.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with confirmed healthcare-associated pneumonia requiring bronchoalveolar lavage and exhibiting severe symptoms.

Not a fit: Patients who do not meet the inclusion criteria, such as those under 18 or over 90, or those lacking consent, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored antibiotic treatments for patients with severe pneumonia.

How similar studies have performed: While the use of molecular panels in pneumonia treatment is becoming common, this specific approach in the emergency department setting is relatively novel and has not been extensively tested.

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)

Where this trial is running

Florence, Tuscany/Italy

• Azienda ospedaliero universitaria careggi — Florence, Tuscany/Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Pelagatti Lorenzo, Dr — AOU Careggi
• Study coordinator: Pelagatti Lorenzo, Dr

Conditions: Pneumonia, Bronchoalveolar Lavage, Antimicrobial Treatment, Sputum, Bronchoalveolar lavage, Endotracheal Aspirate, Antimicrobial treatment, pneumonia