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NCT Number: NCT06506617

HCAPPED I: HCAP-Pcr in Emergency Department

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.

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Key information

Conditions

Pneumonia Abnormalities, Multiple Antimicrobial Treatment Bronchoalveolar Lavage Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities De Lange Syndrome Genetic Diseases, Inborn Infections Intellectual Disability Lung Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Respiratory Tract Diseases Respiratory Tract Infections Sputum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda ospedaliero universitaria careggi

Florence, Tuscany/Italy, 50122, Italy

Location status: Recruiting

Location contact

Pelagatti Lorenzo, Dr

CONTACT

[email protected]

+39 3385917317

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. evaluate the impact of early use of multiplex PCR

    Time frame: 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 outcomes

  1. Time to Antibiotic Escalation or De-escalation

    Time frame: up to 3 months

    Measure the time from hospital admission to the escalation or de-escalation of antibiotic therapy.

  2. Length of Hospital Stay

    Time frame: up to 3 months

    Assess the total duration of the hospital stay.

  3. Need for Escalation of Supportive Therapy:

    Time frame: 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)

  4. Duration of Antibiotic Therapy:

    Time frame: up to 3 months

    Track the length of time antibiotics are administered.

  5. De-escalation of Antibiotic Therapy

    Time frame: 7 days from admission

    Assess the de-escalation of antibiotic therapy within the first 7 days of inclusion in the study.

  6. Escalation of Antibiotic Therapy

    Time frame: 7 days from admission

    Assess the escalation of antibiotic therapy within the first 7 days of inclusion in the study.

  7. Identification of HCAP Etiology

    Time frame: 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.

  8. In-hospital Mortality

    Time frame: up to 3 months

    Measure in-hospital mortality rates for pneumonia and all causes.

  9. 30-day Mortality and Readmission

    Time frame: 30 days from discharge

    Measure mortality rates for pneumonia and all causes, and track readmissions within 30 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Pelagatti Lorenzo, Dr

CONTACT

[email protected]

+393385917317

Pelagatti Lorenzo, Dr

CONTACT

[email protected]

+390557947088

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Acronym: HCAPPED-I

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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