HCAPPED I: HCAP-Pcr in Emergency Department

Last updated: July 16, 2024
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT06506617
CEAVC 26198_oss
  • Ages > 18
  • All Genders

Study 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

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

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

Total Participants: 93
Study Start date:
June 07, 2024
Estimated Completion Date:
January 07, 2026

Connect with a study center

  • Azienda ospedaliero universitaria careggi

    Florence, Tuscany/Italy 50122
    Italy

    Active - Recruiting

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